Identifying the Symptoms of a Loose Knee Replacement

Knee replacements can be an option for someone with severe knee pain and mobility issues. These artificial joints that mimic a natural knee can help restore a person’s ability to do their daily activities. Yet, like any surgical procedure, it comes with the risk of complications. One potential complication is the loosening of the implant.

Overview of Knee Replacement

Knee replacement surgery is also known as total knee arthroplasty. It involves replacing damaged or diseased portions of the knee joint with artificial components. There are two types of knee replacements. They are:

Partial knee replacement: In this procedure, only the damaged part of the knee joint is replaced with an implant. This type of procedure is more common in young adults. It is typically only done to address injury or trauma to one area of the knee.
Total knee replacement: As the name suggests, this procedure involves replacing the entire knee joint. Total knee replacements are the most common type of knee replacement surgery.

The most common reason for a knee replacement is to treat severe osteoarthritis. This condition develops when the protective cartilage between knee bones gradually wears down. This can lead to knee pain and stiffness, making it hard to do everyday activities like walking or climbing stairs.

Other conditions that may lead to knee replacement include rheumatoid arthritis, post-traumatic arthritis, and knee injuries.

The Cost of Knee Replacement Surgery

The cost of knee replacement surgery can vary significantly. Typically, it can range from $20,000 to $70,000. Contributing factors include:

Medical insurance or medical benefits: Each person’s plan is different and variables can include out-of-pocket costs, co-pays, and deductibles.
Hospital stay duration:: A patient’s total stay at the hospital after knee replacement can vary depending on the type of replacement, their individual health factors, as well as progress of recovery.
How long you spend in the hospital after a knee replacement procedure can vary depending on the type of replacement, individual health factors, and your recovery progress. However, the longer your stay is, the more expensive the total cost will be.
Type of implant used: Knee implants are typically made of metal alloys and plastic materials. The surgical approach can also vary. Some surgeons use customized instruments or computer technology to assist in the surgery. All of these factors contribute to the total cost.
Pre Existing conditions: These can affect both the cost and outcome of knee replacement surgery. Individuals with obesity, diabetes, or heart disease may require additional care during and after the procedure, which can result in higher costs.
Location: The cost of knee replacement surgery varies based on the location. Typically, urban areas tend to have higher costs due to factors such as demand and overhead expenses.

Although knee replacement surgery can improve knee function for patients, these artificial joints are not indestructible. Like any other surgical implant, knee replacements can wear down over time or fail for various reasons.

Factors Contributing to Loosening of Knee Replacement

Several factors can contribute to the loosening of a knee replacement implant. These factors vary in severity depending on the individual case, and can be more common in adults over the age of 45. However, they can occur in any age group.

Wear: Over time, if the implant has a plastic surface it can wear down. When this occurs, it can lead to particle-induced osteolysis, which is the body’s response to particles of the implant breaking down and causing inflammation. This can eventually lead to loosening of the knee replacement.
Surgical and implant quality: The surgical technique used and the quality of the implant itself can also contribute to loosening. If the joint is not aligned correctly during surgery or if a low-quality implant is used, it may lead to loosening over time.
High-impact activities: Participating in high-impact activities like running or contact sports can put excessive pressure on the knee replacement. This can cause the artificial components to wear down at a faster rate.
Bone weakening: Conditions like osteoporosis or rheumatoid arthritis can weaken the bone around the implant, making it more prone to loosening.
Infection: In rare cases, an infection can occur around the knee replacement. This can cause inflammation and weakening of the bone. Such an infection can be caused by bacteria entering the body through a wound or during surgery.
Patient’s body weight: Weight can put added stress on the knee replacement, increasing the risk of loosening.
Trauma: In rare cases, a traumatic event such as a fall or accident can cause the knee replacement to become loose.
Implant dislocation: A dislocated implant can cause instability and looseness in the knee joint, leading to complications. This can happen if the joint is not aligned correctly during surgery or due to excessive wear and tear over time or if a patient participates in high-impact activities that put stress on the implant.

7 Common Loosening Knee Replacement Symptoms To Know

If a knee replacement becomes loose, it can cause significant discomfort and limit the ability for knee movement. For some, that can mean difficulty running, jumping, kneeling, or even walking.

Recognizing the symptoms of a loose knee replacement is vital since early detection can lead to better treatment outcomes. The following are seven common symptoms of a loosening knee replacement to be aware of:

1. Pain Ranging from Mild to Severe

Pain is often the first sign of a loose knee replacement. Such pain can range from mild discomfort to severe and constant pain that interferes with daily activities. The pain may be felt around the knee joint and may also radiate to the thigh or the calf.

2. Swelling and Redness

When a knee replacement becomes loose, the friction and irritation from the loose implant can induce an inflammatory reaction in the nearby tissues, resulting in swelling and redness in the knee joint area.

In people with darker skin tones, these changes may be more subtle, so it is important to also look for signs such as tenderness, heat, and texture changes.

In some cases, redness may not always be present during inflammation, and its presence alone does not necessarily indicate the presence of inflammation. Swelling and redness can also be caused by an infection, which is another potential cause of a loose knee replacement.

3. Popping or Clicking Sound

Experiencing a popping or clicking sound while walking, could indicate a loose knee replacement. This is caused by the loosening of the implant components, which may rub against each. In some instances, these sounds may also indicate an implant dislocation. If the artificial components become misaligned, they can produce audible noises when moving.

4. Joint Stiffness

Loosening of the implant can cause inflammation and swelling, leading to joint stiffness and a reduced range of motion. Stiffness is often accompanied by pain and discomfort.

5. Skin Discoloration

Sometimes, a loose knee replacement may cause skin discoloration around the affected area. For example, the skin may appear bruised, bluish, or yellowish due to poor circulation caused by inflammation or damage to the surrounding tissues. This discoloration may accompany other symptoms such as warmth, tenderness, or swelling.

6. Instability

A loose knee replacement can cause instability in the affected knee joint, making it difficult to walk or perform daily activities. Instability can also occur if an implant dislocates. In this case, the artificial components may shift out of their proper alignment, causing issues with stability and mobility.

7. Reduced Range of Motion

If the artificial components become misaligned, they may impede the natural movement of the knee joint, leading to a reduced range of motion. This can make it difficult for patients to perform simple activities like bending their knees or walking up and down stairs.

How Medical Specialists Diagnose a Loosened Knee Prosthesis

When experiencing symptoms of a loosened knee prosthesis, seek medical attention. A physician should conduct a thorough physical exam to diagnose the presence of a loose knee implant.

They will ask about previous surgeries on the affected knee and general medical history, conduct a physical exam, and order additional tests like X-rays, MRI, or CT scans to assess the condition of the knee implant and its surrounding tissues.

Is Surgical Intervention Needed to Correct Loosening?

If a loosened prosthesis is diagnosed, your physician may recommend revision total knee replacement, which is a more complex and invasive procedure than the initial knee replacement surgery.

Revision surgery involves removing the loosened or damaged implant components and replacing them with new ones. It may also include addressing any underlying issues like infection or poor bone quality.

While revision surgery can address a loose knee prosthesis, it carries risks and should be considered carefully. Surgical intervention may not always be the best or only option.

Potential Risks of Revision Surgery

A study shows that 11 to 20.8% of patients who have undergone initial knee replacement surgery experience perioperative complications.

Revision surgery, like any surgery, carries risks such as infection, poor wound healing, bone fractures, and blood vessel issues. These risks can be higher than those of the initial knee replacement surgery.

Understanding what the risks are can help someone dealing with knee conditions to make a more informed decision about treatment options. Like any surgical procedure, the revision surgery should be a last resort and only considered after exploring all other possible solutions.

The following are some potential risks of revision surgery:

Surgical Issues

Revision surgery is an invasive procedure that carries similar and greater risks compared to the initial knee replacement surgery. This is because revision surgery may involve more extensive incisions and bone removal to remove or replace the loosened implant components.

However, that doesn’t mean it’s not a viable option for treating a loose knee prosthesis. Many factors contribute to the outcome of revision surgery, such as the patient’s overall health and age, and the surgeon’s skill. Keeping this in mind, the following are some surgical complications that may occur:

Infection

Revision surgery presents a higher risk of an infection than the initial knee replacement surgery. Previous surgeries can create scar tissue, making it more challenging to access and clean the affected area. Additionally, revision surgery may involve longer operating times, increasing the risk of infection.

The risk of infection varies based on factors such as the patient’s health, medical history, and the surgeon’s experience. However, not all infections are severe, and most can be treated with antibiotics.

Poor Wound Healing

Poor wound healing refers to the slow or inadequate healing of a surgical incision, which could lead to infection as well as a delayed recovery. Since revision surgery involves reopening an old incision or creating a new one, there is a risk of poor wound healing. This is especially true for patients who are older or have certain health conditions that affect wound healing, such as diabetes. The risk of poor wound healing can be reduced by following proper post-operative care instructions and managing underlying health conditions.

Bone Fracture

During revision surgery, the surgeon might need to remove more bone to access or replace the loosened implant components. Doing so can weaken the remaining bone and increase the risk of a fracture during or after the procedure. Bone fractures can prolong recovery time and may require additional surgeries to fix.

They can also result in long-term complications such as instability or reduced range of motion, thereby decreasing quality of life. The risk of bone fracture may vary based on factors such as the patient’s age and overall health. Younger adults in good health are much less at risk of experiencing a bone fracture during revision surgery.

Blood Vessel Issues

Revision surgery can also put patients at an increased risk of blood vessel issues, such as deep vein thrombosis (DVT) or pulmonary embolism. Deep vein thrombosis (DVT) is a condition where blood clots develop in the leg veins, while pulmonary embolism occurs when these blood clots travel to the lungs. DVT is usually not serious and can be treated with anticoagulant medications. However, pulmonary embolisms are serious and potentially life-threatening complications that can occur after surgery.

During revision knee replacement surgery, there is an increased risk of developing DVT due to the longer operating time and the manipulation of tissues. If a blood clot develops and travels to the lungs, it can cause pulmonary embolism. This can be fatal if left untreated.

Although the risk of developing DVT or pulmonary embolism after revision knee replacement surgery is relatively low, it should still be taken seriously.

Circulatory Problems

As mentioned earlier, blood clots can form in the legs after revision surgery, increasing the risk of pulmonary embolism. However, other circulatory issues may arise during or after revision knee replacement surgery. For example, patients may experience swelling or leg pain due to disrupted blood flow. This can be managed with medication and physical therapy.

The risk of circulatory issues following revision surgery is relatively low, but medical professionals should still monitor and manage it to prevent serious complications.

Nerve Damage

Due to the extensive manipulation of tissues and bones during revision surgery, there is a risk of nerve damage or injury. This can result in numbness, weakness, and even paralysis, in rare cases. The risk of nerve damage or injury during revision knee replacement surgery is relatively rare. However, this may vary depending on factors such as the patient’s age and underlying health conditions. Additionally, not all nerve damage or injuries are severe and may improve over time.

Improve Mobility Without Surgery If A Knee Replacement Fails

People who are experiencing persistent symptoms of complications after going through knee surgery should seek medical attention and explore all options before considering revision surgery. Regenexx procedures offer a non-surgical approach to managing knee pain using regenerative medicine that can help improve knee function without surgery.

A Regenexx network physician will use interventional orthopedics to treat the root cause of knee replacement failure. Regenexx procedures can help promote the body’s natural healing abilities, reducing pain and improving function.

Interventional Orthobiologics And Orthopedics Blog – Regenexx

Understanding Knee Bursitis

Knee bursitis is the inflammation of fluid-filled sacs around the knee, known as bursae. It can occur due to repetitive motions, constant pressure on the knee, or injuries, and cause pain, tenderness, and swelling.

When experiencing these symptoms, proper diagnosis is crucial. Symptoms like pain and inflammation might be signs of deeper issues like tendon damage [1].

Common treatments, such as painkillers or corticosteroid injections, can offer short-term relief. However, they don’t solve the underlying problem and can have severe side effects. If left untreated, these problems may lead to long-term pain and complications, as well as an over-reliance on medications.

The Regenexx approach provides a non-surgical alternative to address the causes of knee pain. Interventional orthobiologics can help promote the body’s natural healing processes without the complications associated with surgery or long-term medication use.

Defining the Anatomy of the Knee

The knee is one of the body’s most complex joints. It connects the thigh bone (femur) to the shinbone (tibia). At the front of the knee is the patella, or kneecap. This is a small, triangular bone that protects the main knee joint.

The bones in the knee joint are connected by strong bands of tissue, ligaments and tendons. Ligaments connect bones and stabilize the knee joint. Tendons attach muscles to bones, facilitating movement.

Bursae are small sacs filled with fluid that act as “cushions”. They reduce friction on pressure points between bones and the tendons or muscles near the joints.

Adults have around 160 bursae in the body [2]. They are located around major joints like shoulders, elbows, hips, and knees.

Each knee contains 12 bursae. Five of them play a primary role:

Prepatellar bursa: Located between the skin and the kneecap.
Infrapatellar bursae: Located below the kneecap, they cushion the patellar tendon.
Suprapatellar bursa: Located above the patella, between the thigh muscle and the knee joint.
Pes anserine bursa: Located on the inner side of the knee, under the hamstring tendon.
Semimembranosus bursa: Located on the inner side of the knee, near the semimembranosus muscle.

What Is Bursitis of the Knee?

Knee bursitis affects one in every 10,000 people every year [1]. It occurs when one or more of the bursae in the knee become inflamed, damaged, and irritated. Causes include repetitive motion, prolonged pressure on the knee, or complications from an injury or infection.

Swelling is a common symptom of bursitis. It occurs when the body’s inflammatory response sends more fluids to the injured area. Other symptoms include pain, tenderness, and warmth around the knee.

Different Types of Bursitis of the Knee

Common types of knee bursitis include:

Prepatellar bursitis: This type of bursitis affects the bursa located in front of the kneecap (patella). It is usually known as “coal miner’s knee,” “carpenter’s knee” or “housemaid’s knee.” It results from frequent kneeling on hard surfaces.
Pes anserine bursitis: This occurs at the bursa situated on the inner side of the knee, just below the joint. This bursa is similar in appearance to a goose’s foot. Pes anserine bursitis is often caused by overuse, obesity, or sports like running. Its symptoms worsen when climbing stairs or due to other weight-bearing activities.

Other types of bursitis are less common. They include:

Infrapatellar bursitis, affecting the bursa below the kneecap
Suprapatellar bursitis, affecting the bursa above the kneecap

Identifying the Signs and Symptoms

Knee bursitis symptoms develop over time. They progress from mild discomfort to pain that impacts daily activities. Their location varies depending on which bursae is affected.

Pain and Tenderness

Pain and tenderness are common in the initial stages of bursitis. They occur when the body’s inflammatory response causes the build-up of fluids around the injured area. These fluids compress surrounding tissues and lead to discomfort.

Patients often describe knee bursitis pain as an aching or burning sensation. Discomfort can intensify with movement or pressure on the affected area, like kneeling.

Localized Knee Swelling

Swelling results from the build-up of fluid around the affected bursa. Fluid build-up causes puffiness around the joint. It can also form a soft lump that is visible when comparing the affected knee to a healthy one.

Warmth Around the Knee

An injured or irritated bursa triggers the inflammatory response. Inflammation increases the blood flow to the injured area to deliver oxygen, nutrients, and healing factors. The blood flow increase causes a sensation of warmth in the area, even when the rest of the body feels cool.

Causes of Bursitis of the Knee

The causes of knee bursitis can vary. Around 70% of knee bursitis cases arise from repetitive stress [3], injury, trauma, or mechanical issues.

Repetitive Irritation

Repetitive movements or pressure on the knee can irritate and inflame the bursa. These movements include frequent kneeling, jumping, or running.

These activities can also affect the nerves around the bursae. Impacted nerve endings influence how forces are distributed in the knee joint during activities like running or walking. Over time, this imbalance can cause the bursae to become inflamed.

Injury and Trauma

Direct injury to the knee causes acute inflammation, leading to bursitis. Traumatic events that cause injured bursae include falls and car accidents. The bursae can also become injured when nearby components are damaged, like knee ligaments, tendons, and bones.

Inflammation typically eases down once the underlying injury has healed. However, sometimes it remains active for long periods. This leads to chronic pain, swelling, and mobility issues.

Bacterial Infection

In some cases, the bursae can become infected by bacteria. This condition is called septic bursitis. 80-90% of cases of septic bursitis are caused by the Staphylococcus aureus bacteria [4].

Often, infection results from a cut or wound near the knee that allows bacteria to enter. However, bacterial infections can also be a complication of surgical interventions like knee replacement surgery.

Low Back Issues

Problems with the back’s alignment, like scoliosis or bad posture, can change walking patterns and stress knee tendons. This stress leads to bursitis and knee inflammation.

In particular, having flat feet increases the risk of Pes anserine bursitis [5]. They misalign the limbs, increasing pressure on the knee’s inner side, where this bursa is located.

Additionally, spinal nerves control leg movement and feeling. If they’re squeezed, irritated, or damaged, it can cause referred pain. This pain might appear as knee pain and numbness but actually start in the spine.

Spinal nerves control leg movement and sensation. When these nerves are pinched, they can weaken muscles, leading to extra strain on tendons, especially near the knee. This problem often worsens with a tight iliotibial (IT) band, a tissue that runs along the outer thigh. A tight IT band can pull the knee out of alignment, causing pain. Even though the issue starts in the spine, it shows how nerve problems, muscle weakness, and tendon strain are connected, with the knee being especially affected.

It’s vital to pinpoint the pain’s source for proper treatment. For example, using topical anti-inflammatory drugs on the knee won’t help if the pain comes from a pinched nerve in the back.

Other Underlying Medical Conditions

Diseases like rheumatoid arthritis or gout can cause body-wide inflammation.

Other conditions that may increase the risk of bursitis include diabetes and degenerative diseases. For instance, NIH research notes that pes anserine bursitis affects about a quarter of diabetics, more often women [5]. A 2015 study showed that 20% of 85 knee osteoarthritis patients had pes anserine bursitis [6]. This rate was much higher than in the general population.

Bursitis risk can also be increased by:

Conditions like syphilis and tuberculosis, which cause mild, widespread inflammation.
Factors that weaken the immune system, like chronic steroid use and hemodialysis.
Autoimmune diseases and gout

Understanding the Vulnerable or At-Risk Groups

Some demographics are more prone to knee bursitis because of risk factors like:

Aging population: With age, tendons lose elasticity and become more prone to damage. This makes older adults more prone to bursitis. A 2014 study shows that 80% of all patients with knee bursitis are males aged between 40 and 60 [7].
Athletes: High-impact sports like running, basketball, and football involve repetitive knee stress. This can cause tendon damage and bursitis. One study shows that pes anserine tendo-bursitis, which is the inflammation of both tendons and the bursae, accounts for 2.5% of knee pain cases in athletes [8].
Manual laborers: Occupations that require frequent kneeling or heavy lifting, such as construction work, can cause repetitive irritation. This leads to a higher rate of bursitis among these workers [9].
Obese individuals: Excess weight puts additional pressure on the knee joints. This increases friction and the risk of bursae inflammation. A 2021 study found that obese individuals have a higher risk of inflammatory joint conditions [10].

Potential Complications of Untreated Knee Problems

Letting knee bursitis go untreated can lead to complications, including ongoing inflammation and the development of other knee conditions.

Ongoing knee problems can progress into more serious conditions like osteoarthritis, meniscal injuries, and cartilage degeneration. Untreated bursitis may also cause the bursae to tear or rupture. This can severely affect knee mobility.

Bursitis itself doesn’t cause more injury but indicates there’s a problem. Severe knee damage, along with bursitis, may need surgery. However, surgery can bring extra risks like infection and further knee damage.

A focus on the importance of an accurate diagnosis

Prompt treatment of knee bursitis is crucial. However, treatment should not be limited to just taking painkillers to numb the pain. If underlying issues such as tendon damage, osteoarthritis, or spinal misalignments are present, painkillers will not address the root cause of the condition.

Additionally, relying on painkillers can expose patients to side effects and delay an accurate diagnosis by masking the pain. This can lead to undiagnosed and untreated symptoms, resulting in further complications.

Diagnosing Bursitis of the Knee

Physicians employ several diagnostic methods to determine the root cause of pain:

Clinical examination: This initial physical assessment involves checking for visible signs. These include swelling, tenderness, and reduced range of motion.
Medical history: A physician may evaluate past injuries or conditions that could be contributing to current symptoms. This helps determine the cause of pain.
X-rays: These scans can help visualize bone structures. They are also used to rule out fractures or arthritis.
MRI (magnetic resonance imaging): These tests provide detailed images of soft tissues. These images help identify tendon damage, inflammation, or fluid buildup in the bursae.
Ultrasound: Ultrasound scans are effective tools for assessing soft tissue swelling and fluid build-up in real-time.
Aspiration: This process involves extracting fluid from the bursae with a needle. The samples are analyzed in a laboratory to rule out infection. As we’ll see below, this technique also has therapeutic applications beyond diagnostic ones.
Blood tests: Specific blood tests can help identify systemic conditions like rheumatoid arthritis or infections.

Diagnosing knee bursitis itself can be straightforward because of the characteristic swelling. However, identifying the underlying cause can be more complex. Root problems may include hidden tendon damage, spine misalignments, and conditions like osteoarthritis.

Advanced diagnostic methods and comprehensive evaluations, such as the ones performed as part of the Regenexx approach, are crucial for accurate diagnosis and treatment.

Using the industry-leading SANS evaluation method, physicians in the Regenexx network can examine the body in motion and review existing imaging (MRI and/or X-Ray). They also often use ultrasound to observe the inner workings of the joint in real time. Combined, these evaluation methods allow physicians in the Regenexx network to get a more accurate picture of what is contributing to symptoms, how function has been affected, and ultimately, the root cause of pain.

Conventional Treatment Approaches to Bursitis of the Knee

Painkillers and at-home remedies may offer short-term relief. However, they do not address the underlying causes of inflammation and may carry severe risks. Because of this, treatment should begin with an accurate diagnosis.

At-Home Relief

At-home pain relief often involves the RICE method: rest, ice, compression, and elevation. This method works by reducing pressure on the knee. It also slows down the blood supply to the injured area. This decreases stress on the joint, inflammation, and swelling.

However, a 2021 study shows that icing may hinder the recovery process [11], indicating it may be less effective than previously thought.

Over-the-Counter/Prescribed Medications

Pain medications work in different ways to alleviate discomfort and swelling. Some of the most common include:

NSAIDs (nonsteroidal anti-inflammatory drugs): Medications like ibuprofen or naproxen reduce inflammation and relieve pain. They work by blocking the production of inflammatory agents known as prostaglandins. They are often used as a first-line defense against acute injuries but don’t not address the underlying cause of inflammation. A 2004 study suggests that long term use of NSAIDs are responsible for 30% of hospital admissions for adverse drug reactions (ADRs) [12], mainly due to bleeding, heart attack, stroke, and renal damage. In addition, a 2011 study suggests that NSAIDs increase the risk of a cardiac event by as much as 82%.
Corticosteroid injections: Corticosteroids are the manufactured version of cortisol. Cortisol i
s a hormone naturally produced by the body that helps regulate inflammation. These injections can provide temporary pain relief. However, repeated use can damage cartilage and disrupt normal cortisol production [13].

Septic bursitis, caused by infection, may require prescription medications to prevent further complications. Infection should be treated rapidly with antibiotics. It may also require surgical drainage to remove the infected fluid.

Surgical Interventions

Surgery is rarely necessary for bursitis and is considered only in severe cases. Common surgical options include:

Aspiration: This involves draining excess fluid from the bursa to reduce swelling and discomfort.
Bursa removal (bursectomy): In severe cases, the inflamed bursa may be surgically removed.
Tendon repair: Addressing any underlying tendon damage may help prevent recurrent bursitis.

Surgery does not guarantee a pain-free outcome. Many patients may continue to experience pain. Sometimes, they also require additional interventions. A 2011 study was conducted on 60 patients who received surgery for prepatellar bursitis. Among these, 20% still experienced pain at follow-up, and three patients required repeated aspirations [14].

Why Choose a Non-Surgical Approach for Knee Health Care?

Today, interventional orthobiologics provide viable non-surgical options for treating knee bursitis without the risks and complications associated with surgery. Common options include platelet-rich plasma (PRP), and bone marrow concentrate (BMAC) injections.

However, not all interventional orthobiologics are the same. Regenexx procedures offer customizable cell concentrations. These can be tailored to each patient and their condition or injury needs, ranging from 6X to 20X. The 20X concentration of stem cells contained in bone marrow far exceeds what is generally achievable by non-Regenexx providers.

These alternatives use the body’s natural healing processes at the injury site. In turn, they may reduce the need for surgery.

How Physicians In The Regenexx Network Approach Knee Conditions

Regenexx’s non-surgical procedures leverage the body’s natural healing abilities. This could help patients manage musculoskeletal conditions, including bursitis, tendon damage, and chronic conditions like arthritis.

Physicians in the Regenexx network will customize each treatment plan based on the diagnosis and patient’s needs. They may use one or a combination of the interventional orthobiologic procedures below.

Regenexx-SD

The Regenexx-SD procedure includes a patented protocol that utilizes Bone Marrow Concentrate (BMC) which contains the patient’s own mesenchymal stem cells. The cell processing for a Regenexx-SD procedure routinely achieves 20x concentration of stem cell-containing bone marrow — far above what non-Regenexx providers achieve.

Regenexx-SCP

The Regenexx-SCP procedure pioneered by Regenexx represents a supercharged version of platelet-rich plasma (PRP). In this procedure, blood is drawn, then processed to isolate the platelets and growth factors. The growth factors are then purified, concentrated, and injected into the knee area using imaging guidance for precision. Regenexx-SCP provides a higher concentration of growth factors compared to standard PRP procedures

Regenexx-PL

Regenexx-PL is a highly specialized derivative of platelet-rich plasma (PRP) with a faster and more concentrated release of growth factors compared to traditional PRP. Regenexx’s proprietary platelet-lysate processing technology has evolved through multiple generations. PL is often combined with other treatments like Super Concentrated Platelets (SCP) and bone marrow concentrate.

Prognosis of Knee Bursitis

Mild knee bursitis from frequent kneeling typically resolves within a few weeks. However, the condition may indicate underlying issues such as tendon damage or spinal misalignment, leading to recurring symptoms. Physicians in the Regenexx network can diagnose the root cause of pain and determine if a non-surgical treatment plan is right for the patient.

References

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InformedHealth.org [Internet]. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2006-. Overview: Bursitis. [Updated 2022 May 4]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK525773/
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Interventional Orthobiologics And Orthopedics Blog – Regenexx

Heading Back Out for Another Sailing Sabbatical

I am headed back out to Italy for our fall sailing sabbatical. My last trip was in the late spring, and this one will be early this fall. Let’s dig in.

Slowing Down on Long-Form Blogs

I’ve been reducing my long-form blogs in favor of daily morning LinkedIn posts. Here are the last few of those:

I’ll be posting every morning on LinkedIn while on my sailing trip. That said, when some crazy stem cell Wild West issue comes up, or some great new study in orthobiologics comes to light, I will still blog.

My Sabatticals

As I have written before, my father got very sick with Diffuse Lewey Body before he and my mom ever had a chance to travel after raising seven kids and giving all of them a chance to go to college. That’s me on the left above and my dad on the right (after he had already entered the throes of that nasty neurodegenerative disease). We are at the Vatican getting ready to see Pope John Paul. That was one of his final wishes, as he was a devout Spanish Catholic.

I grew up a firmly middle-class kid, so whatever was going to happen in my life needed to be up to me to make happen. Those two experiences, plus being a physician and caring for sick people, taught me that you never know what’s around the corner in your health journey. You can try everything you want and control what you can, and that certainly improves your odds of staying active and healthy as you age, but it’s best to get out and live a little while you’re still able. So, I cooked up this epic European journey many years ago during the pandemic to push myself to get out there before I officially retired.

Our Upcoming Journey

We will start this time on the island of Elba, where Napoleon was placed the first time he was captured. We will then head for the Italian coast and then head south to Rome, Naples, and the Amalfi coast. We will end up near Palermo in Sicily. We will leave the boat there in a marina for the winter.

DIY vs. Chartering

When some people think sailing in the Tyrrhenian Sea, they think of experiences they see on shows like “Below Decks,” where super-rich people charter mega-yachts and have a large crew at their disposal to satisfy every whim. That is NOT what we do. We have a crew of two people- my wife and I. I’m also the Captain/boat maintenance guy, and there’s always something to fix, maintain, or otherwise deal with. For example, our main radio and chart system was acting up this past trip, so I had to rely on backups for both while trying to diagnose the problem. This trip, I have a pretty long list of things to catch up on.

Having said that, we love the sense of freedom the sea provides. We spend a couple of hours sailing, head into a marina at the next spot, have a nice exploration, then dinner, and then decide if we want to head down the road or stay put.

Following Our Trip

I don’t use social media to document our lives other than while sailing twice a year. This began as a way to inform our kids where we were and allow them to see we were safe. Then I invited a few friends, and finally, my patients asked, so I invited them as well. That feed is here on Instagram. I have to warn you: the only time I check Instagram is when we are sailing.

The upshot? I look forward to returning to the water and exploring the rest of the Italian west coast and Sicily! I will be posting daily on LinkedIn and may write a blog or two while I’m gone!

Interventional Orthobiologics And Orthopedics Blog – Regenexx

mVASC is Ground Up Cadaver SubQ Tissue? Huh?

Sometimes, you really can’t make stuff up in this field. This weekend, a colleague emailed me asking if I knew anything about mVasc, as one of his patients had been told it could effectively treat knee and ankle arthritis. I had never heard of this tissue, so I looked it up. It turns out it’s ground-up cadaver subQ tissue. After an analysis of this stuff, I’m still scratching my head. Let’s dive in.

What the Heck is mVASC?

mVASC is an allogeneic tissue product produced by a San Diego company called MicroVascular Tissues. This is from the website:

So basically, the company takes subcutaneous tissue from cadavers and lyophilizes it. Given that the patient wanted this injected into his joints and that the company has a white paper case study on a knee arthritis patient, I will have to assume that once you reconstitute it, it’s an injectable mush.

Using mVASC for Knee OA?

My colleague sent me the above flyer that was given to his patient. It’s a case study of a single patient with KL 3 knee OA injected with mVASC. The substance was reconstituted with three cc 0.25% Marcaine, and the mVASC solution was injected into each knee. These were the reported results:

The graph above shows reported pain relief.

Given that we know Marcaine is chondrotoxic, reconstituting this stuff in a substance that can damage cartilage, IMHO, is ill-advised.

Other mVASC Research

I searched the US National Library of Medicine (Pubmed) for peer-reviewed and published mVASC articles. I found a single paper published in 2020 on wound healing (1). The in-vitro data and animal model focused on the angiogenic properties of mVASC. The clinical study was a small case series of three non-healing wounds treated with mVASC.

PRP Much?

When my colleague told me the mVASC website had convinced a patient of his to get his knee and ankle arthritis treated with this stuff, I have to admit that, knowing what I know about Regenerative Medicine, I laughed out loud. Cadaver subQ tissue? Really? After reviewing the information, I’m still scratching my head. However, all of this is a great example of how low information patients can get swayed by a sales machine.

First, there are almost 150 peer-reviewed and published randomized controlled trials on platelet-rich plasma, with several dozen publications focused on treating knee arthritis. For that one diagnosis, there are thousands of patients treated in the world’s most sophisticated study designs who had success with PRP. In this case, that’s compared to a single patient in this unpublished white paper. That’s like comparing a beat up 1980’s Chevy with its engine missing to a new Ferrari for how fast both can make it around the track. See below for that comparison:

MFat?

SubQ tissue is fat. Compared to mVASC, there are about a dozen much larger and more advanced studies using your own SubQ tissue taken by liposuction and chopped up on knee arthritis, showing this treatment works well (2-6). So, if someone was really into using subQ tissue, that treatment is called micro fragmented fat, or MFat. If you’re like most Americans, you have plenty of that stuff ready to be harvested and used to treat your arthritic knee.

Safety

mVASC is a 361-registered donor tissue. Given the problems with sterility and processing found in multiple small labs selling 361 birth tissues, IMHO, any off-the-shelf 361 from a small company would earn my concern on safety. Here are multiple FDA Warning letters about those problems:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/invitrx-therapeutics-inc-630712-11092022https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/signature-biologics-llc-631039-09182023

https://www.fda.gov/news-events/press-announcements/fda-sends-warning-companies-offering-unapproved-umbilical-cord-blood-products-may-put-patients-riskhttps://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/neobiosis-llc-662985-06052024

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/renatilabs-inc-646353-06012023

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stratus-biosystems-llc-dba-cellgenuity-regenerative-science-631303-06052023

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/smart-surgical-inc-dba-burst-biologics-614361-02022022https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genetech-inc-561808-11292018

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vitti-labs-llc-627699-07282022https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/row1-inc-dba-regenative-labs-638823-06212023

Regulatory

mVASC is a 361 donor tissue. That means that there is no FDA approval. The company only has to complete a 45-minute free online registration. Compare that to an FDA-approved drug requiring 5-7 years of clinical trials and hundreds of millions of dollars of research.

Because this is a simple 361 tissue registration, the company is VERY limited in what it can say about mVASC. Meaning the most it can say is that it is a tissue, this is where it’s from, and maybe here’s what’s in this tissue (i.e., growth factors). It can’t advertise any suggested uses for the tissue or data showing what happens when it is used in patients. Regrettably, IMHO, the company selling mVASC has already crossed that line, as we find this front and center on its website:

The FDA regulates tissues based on the claims made. If you stay on the side of a 361 registration by not making treatment claims, you can get away with the free 45-minute registration. If you make a treatment claim (IMHO, like the one above), you MUST go through full clinical trials as a 351 drug BEFORE selling your tissue. Marketing that tissue before that FDA drug approval and the years of clinical trials it requires makes the substance you’re selling a misbranded and unapproved drug. IMHO, that’s the category where mVASC lives right now.

The upshot? Given the mature data on PRP and the evolving literature on MFat, would I let someone inject ground-up cadaver subQ tissue into my knee? No way. It’s also disappointing to see yet another 361 tissue company, IMHO, playing fast and loose with treatment claims. If the company believes mVASC is the best thing since sliced bread, then great, do the clinical trials and work with the FDA to get it approved as a new drug.

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References:

(1) Dobke M, Peterson DR, Mattern RH, Arm DM, Li WW. Microvascular tissue as a platform technology to modify the local microenvironment and influence the healing cascade. Regen Med. 2020 Feb;15(2):1313-1328. doi: 10.2217/rme-2019-0139. Epub 2020 Mar 31. PMID: 32228366.

(2) Baria M, Barker T, Durgam S, Pedroza A, Flanigan D, Jia L, Kaeding C, Magnussen R. Microfragmented Adipose Tissue Is Equivalent to Platelet-Rich Plasma for Knee Osteoarthritis at 12 Months Posttreatment: A Randomized Controlled Trial. Orthop J Sports Med. 2024 Mar 18;12(3):23259671241233916. doi: 10.1177/23259671241233916. PMID: 38510323; PMCID: PMC10953019.

(3) Russo A, Cortina G, Condello V, Collarile M, Orlandi R, Gianoli R, Giuliani E, Madonna V. Autologous micro-fragmented adipose tissue injection provides significant and prolonged clinical improvement in patients with knee osteoarthritis: a case-series study. J Exp Orthop. 2023 Nov 16;10(1):116. doi: 10.1186/s40634-023-00668-y. PMID: 37968496; PMCID: PMC10651566.

(4) Yu Y, Lu Q, Li S, Liu M, Sun H, Li L, Han K, Liu P. Intra-Articular Injection of Autologous Micro-Fragmented Adipose Tissue for the Treatment of Knee Osteoarthritis: A Prospective Interventional Study. J Pers Med. 2023 Mar 10;13(3):504. doi: 10.3390/jpm13030504. PMID: 36983686; PMCID: PMC10059754.

(5) Fan F, Grant RA, Whitehead JP, Yewlett A, F Lee PY. An observational study evaluating the efficacy of microfragmented adipose tissue in the treatment of osteoarthritis. Regen Med. 2023 Feb;18(2):113-121. doi: 10.2217/rme-2022-0110. Epub 2022 Dec 21. PMID: 36541936.

(6) Ferracini R, Alessio-Mazzola M, Sonzogni B, Stambazzi C, Ursino C, Roato I, Mussano F, Bistolfi A, Furlan S, Godio L, Alotto D, Formica M. Age and synovitis affect the results of the treatment of knee osteoarthritis with Microfragmented Autologous Fat Tissue. Knee Surg Sports Traumatol Arthrosc. 2023 Sep;31(9):3655-3664. doi: 10.1007/s00167-022-07139-4. Epub 2022 Sep 10. PMID: 36087128; PMCID: PMC10435636.

Interventional Orthobiologics And Orthopedics Blog – Regenexx

Research Updates on the Bedside Dosing of Bone Marrow Concentrate

Now that dosing PRP has become a good thing, the next domino to fall for dosing is bone marrow concentrate. Up until this past month, outside of our 2014 paper, there wasn’t much out there about a simple bedside method to get to the right dose. Now, with several new papers being published, has that changed?

Orthobiologics and Dose

Dosing is ignored in no other area of medicine because the dose is often critical for treatment success. However, in orthobiologics, 99% of the clinics you could go to have no idea of the dose of PRP or BMC that they’re injecting. That’s NEVER been the case at Regenexx, where dose has been a thing since we began in 2005. These past few years, advanced orthobiologics practices have begun to pay attention to PRP dose. That’s wonderful, and we welcome the company, but regrettably, even for PRP, the likelihood of finding that type of clinic is still like finding a needle in a haystack.

Bone Marrow Concentrate Dosing

Several studies correlate the stem cell content of bone marrow concentrate with clinical outcomes (1-3). The higher the stem cell content, the better the outcomes. The problem is that there are only two surefire ways to measure stem cell content; neither of these is something a doctor’s office can do.

The two ways to measure the stem cell content of BMC are CFU-f counts and CD-271 flow cytometry counts.

CFU-f

CFU-f stands for Colony Forming Unit-fibroblast assay, which is shown above in plates I grabbed from our research lab. The purple colonies each represent a stem cell in the diluted BMC that was plated. Hence, this provides a rough count of the mesenchymal stem cell content. However, there are a few caveats with CFU-f counts:

They require 10-14 days of culture, so they can’t be used to dose cells at the bedside.
The counts can vary widely between different labs and plating techniques, so they can’t be compared between labs and are only validated within one lab to check counts between samples.

CD-271

Above, you see a rare event flow cytometer with acoustic focusing. Again, I just went into our research lab and snapped this pic. While this scientific instrument can measure many different markers on the surface of cells, the CD271 marker has become the default for counting mesenchymal stem cells (4). This is not your average flow cytometer, as it was designed to detect rare events like MSCs. While it could theoretically be used to get a stem cell count on the same day as a procedure, it takes a highly trained tech or PhD to interpret the results, as complex gating is required to ID these rare hits. Hence, again, this is NOT practical for measuring stem cell counts in BMC at the bedside in the average orthobiologics clinic.

BMC Counts at the Bedside-TNCC

Can we do a count at the bedside to get an idea of how many stem cells are probably in a sample? Yes, we can count Total Nucleated Cells, which is a rough estimate of the number of stem cells. We introduced this concept in a 2014 study where the decrease in knee pain was associated with >400 million TNCC delivered into the knee (7). However, nobody else has used this simple metric until a spate of recently published new studies.

The New Research

The new papers are from studies that included only moderate knee osteoarthritis (KL 2-3) (5,6). These graphs are from my Regenexx Morning Orthobiologics Update on Linkedin.

In the first study, they dosed the BMC by the patient’s weight, giving 1 million cells per Kg in one group, 2 million cells per Kg in a second group, and 5 million cells per Kg in a third group. Above is what they found. Basically, the 2 and 5 million cells per Kg doses worked the best, while 1 million cells per Kg was too low a dose.

In the second study (graph above), the doctors used 10M, 50M, and 100M cells, and they saw good results in pain and imaging findings in the medium and high-dose cell groups (50M and 100M cells). Again, the second study documented improvements in imaging, which is pretty cool.

Above is how the two studies stack up total TNCC doses in the average man and woman. The first study would have even higher doses for overweight people, and those are shown below:

So, a great question would be, were there overweight patients in these studies? Muthu’s mean BMI was 25, just on the high side of normal weight/mildly obese. For Jeyarman, the BMI was higher at around 27, which is mildly obese. So, many of the Jeyerman patients were given doses above the normal weight ranges I listed above, about 150M to 375 million.

What We Know Now About TNCC, BMC, and Knee OA

So, how do all of these studies line up? If you had to come up with a TNCC dose, on the low side would be the Muthu study at 50M cells, and on the high side would be the Centeno study at 400M cells. Jeyerman would be in the middle at 100-250M cells for most patients (more similar to Centeno if the patient is overweight). In our study, we also had some KL4 knees (severe OA), and our average BMI was 27, similar to Jeyerman. In addition, our patients and those in Jeyerman were older, in their mid-50s, as opposed to Muthu where patients were in their late 40s. Finally, both new studies were done in India and ours in the US, so I am unsure if that has an impact. In addition, both Indian studies included a population of patients with type 2 DM, whereas our study had very few of these patients.

Final Dosing Recommendations

Can we draw any conclusions from these three studies focusing on TNCC dosing? Here is my take:

For younger, non-obese patients with moderate knee OA, based on these studies, 100-200M cells in a knee would be a reasonable target.
For older, heavier patients with more severe knee OA-400M cells would be a good target.

The upshot? Seeing these two new authors building on our 2014 work and taking it a few steps forward is wonderful. We are also working on a new paper that will look more closely at TNCC vs. CFU-f relationships to see if dialing in this type of dosing might be possible.

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References:

(1) Centeno CJ, Berger DR, Money BT, Dodson E, Urbanek CW, Steinmetz NJ. Percutaneous autologous bone marrow concentrate for knee osteoarthritis: patient-reported outcomes and progenitor cell content. Int Orthop. 2022 Aug 6. doi: 10.1007/s00264-022-05524-9. Epub ahead of print. PMID: 35932306.

(2) Pettine KA, Murphy MB, Suzuki RK, Sand TT. Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months. Stem Cells. 2015 Jan;33(1):146-56. doi: 10.1002/stem.1845. PMID: 25187512.

(3) Hernigou P, Beaujean F. Treatment of osteonecrosis with autologous bone marrow grafting. Clin Orthop Relat Res. 2002 Dec;(405):14-23. doi: 10.1097/00003086-200212000-00003. PMID: 12461352.

(4) Álvarez-Viejo M, Menéndez-Menéndez Y, Otero-Hernández J. CD271 as a marker to identify mesenchymal stem cells from diverse sources before culture. World J Stem Cells. 2015 Mar 26;7(2):470-6. doi: 10.4252/wjsc.v7.i2.470. PMID: 25815130; PMCID: PMC4369502.

(5) Muthu S, Ramanathan K, Alagar Yadav S, Jha SK, Ranjan R. Increased Cellular Dosage of Bone Marrow Aspiration Concentrate Does Not Translate to Increased Clinical Effectiveness in Knee Osteoarthritis: A Phase I Dose Escalation Study. Indian J Orthop. 2024 Jun 5;58(8):1001-1008. doi: 10.1007/s43465-024-01197-1. PMID: 39087042; PMCID: PMC11286881.

(6) Jeyaraman M, Karthik KS, Choudary D, Jeyaraman N, Nallakumarasamy A, Ramasubramian S. Autologous Bone Marrow Aspiration Concentrate (BMAC) Therapy for Primary Knee Osteoarthritis-An Observational and Dose Escalation Study. Indian J Orthop. 2024 Jun 7;58(8):1016-1026. doi: 10.1007/s43465-024-01194-4. PMID: 39087054; PMCID: PMC11286920.

(7) Centeno CJ, Al-Sayegh H, Bashir J, Goodyear S, Freeman MD. A dose response analysis of a specific bone marrow concentrate treatment protocol for knee osteoarthritis. BMC Musculoskelet Disord. 2015 Sep 18;16:258. doi: 10.1186/s12891-015-0714-z. PMID: 26385099; PMCID: PMC4575428.

Interventional Orthobiologics And Orthopedics Blog – Regenexx

Regenexx Morning Orthobiologics Update

This past week, I’ve been involved in creating a new daily content feature on Linkedin called the “Morning Orthobiologics Update”. Let’s dig in.

Our Scrolling World

Like many people, I get bombarded with new information. Have you ever noticed that you clicked on something, and then your social media feeds began to show you that thing? Because of this information overload, people read fewer long-format pieces. Instead, most of their consumption is small bits of information that can be digested in 5-10 seconds. Sometimes, they’ll watch a few minutes of a video if they’re interested in a deep dive.

Figuring Out How to Boil Down Complex Science to 10 Seconds

This past week, I began the “Morning Orthobiologics Update” on Linkedin. It’s basically the money shot from a study or something else about orthobiologics that can be digested in 10 seconds or less, but that will teach the reader something critical. I do the heavy lifting of reading the study and then boiling down that information into a single image. The good news is that it’s pretty easy for me to do after almost 20 years of writing blogs. I also include the link to the actual research if someone wants to dive in deeper.

How to Get Your Morning Orthobiologics Update?

First, I have a LinkedIn channel: https://www.linkedin.com/in/chris-centeno-m-d-b6838024/. So, if you’re on LinkedIn, click the follow button to get the morning update. If you’re not on LinkedIn, I’m going to have our Regenexx web team begin scraping those from LinkedIn and sending them to the blog subscriber role via email. I also have a YouTube channel where I’m more heavily focused on helping the craniocervical instability community understand that topic, but I also cover general orthobiologics. See https://www.youtube.com/channel/UCvD7CJJbzLkI45qcRgeT3OA

The upshot? I’ll still be blogging when I have something I need to get out there that requires a longer format. However, I also like this daily Linkedin update format. Remember, one of the reasons I began blogging was to keep myself updated on the latest scientific literature that I could use to help my patients make the best decisions. Blogging, making videos, and now the Morning Update force me to stay on top of that huge mountain of research published daily.

Interventional Orthobiologics And Orthopedics Blog – Regenexx

Knee Ligament Laxity vs. Torn Ligaments: Interventional Orthobiologics vs. Surgery

There’s an interesting duality between the understanding that loose ligaments should be treated with orthobiologics and the old-school orthopedic surgery approach that only completely torn ligaments are important and can be operated on. This was recently thrust into my consciousness by a sports medicine physician with whom I shared a patient who doggedly claimed that this patient had “intact” ligaments that didn’t need to be treated. Let’s explore this important issue this morning.

The Controversy

For decades, a mainstay of orthopedic surgery has been ACL reconstruction. In that world, the ACL is either torn/damaged enough to need replacement, or the patient needs physical therapy. There is often no or little middle ground. However, we know that, like any ligament, the ACL can also be lax. Loose ligaments lead to joint instability, which can cause degenerative joint disease. Hence, with the advent of orthobiologics, determining if an ACL is loose becomes essential. Targeting a lax ACL for treatment is also important.

Many orthopedic practices have begun to add simple orthobiologics, and some have begun hiring non-surgical sports medicine physicians to take over that part of the practice. Recently, I came across a sports med doctor who, IMHO, viewed a patient’s ACL with a surgical binary lens like an orthopedic surgeon. In other words, since the MRI was read as normal and since his more surgically focused exam didn’t show a blown ACL, the patient’s ACL shouldn’t be treated.

This morning, I would like to dive into the controversy as we have two points of view. One states that we need to expand our physical exam skills once we add orthobiologics and identify and treat all lax ligaments that could be causing joint degenerative changes, and the other uses the surgical paradigm that an ACL that looks “intact” shouldn’t be treated.

The Patient

A woman I have known for years was upping her workout game last year when her knee began to hurt. A careful history revealed that when she was younger, a several thousand-pound horse fell on that knee, and while it seemed to heal up since then, that knee was never perfect and always felt “loose.” Her MRI showed moderate cartilage loss under her kneecap and a degenerative lateral meniscus tear. Her exam in my hands showed ACL/ALL, MCL, and LCL laxity, so the treatment plan was clear that we would use PRP intra-articular (IA) and into these lax ligaments. As the treatment unfolded, a sports medicine physician embedded in a local orthopedic surgery group she had also seen was adamant that her “ACL was intact” based on his exam and her knee MRI. He also wanted to inject PRP IA but asserted that she didn’t need ligament injections.

The Traditional Orthopedic Surgery Approach

The good news was that both the sports med doctor and myself agreed that meniscus surgery in a 60+-year-old woman was a non-starter. However, I feel largely because of differences in training and practice environment, the sports med doctor didn’t understand that with orthobiologics, the goal should be to look for mild ligament laxity and, if found, restore knee stability back to or as close to normal as possible. Given that this speaks to a much larger issue that IMHO prevents PRP from reaching its full societal benefit for patients, I thought it was worth a blog.

Ligament Laxity (sub-failure) vs. Ligament Rupture

Let’s face it: orthopedic surgery has focused on ACL injuries that require surgical reconstruction. These are large tears where the ligament is usually completely torn and retracted and is non-functional, causing severe knee instability. However, other types of ligament injuries exist as well.

Ligament injuries are graded 1-3 (1). Grade 1 is damage to the fibers (micotears that can result in laxity), grade 2 is partial tearing, and grade 3 is a complete ligament rupture. I diagnosed this patient with a grade 1-2 ACL injury in addition to knee osteoarthritis. That means that she could have anything from microtearing of her ACL to a partial occult tear.

In my opinion, one of the things that the sports medicine doctor fixated on was the normal MRI read of her ACL. So let’s look at the accuracy of MRI in detecting an ACL rupture (grade 3, a more severe injury than the one discussed here-see the discussion below on sub-failure instability) (7). For those more severe injuries:

“MRI findings for the ACL yielded 60 true-positives (were confirmed on arthroscopy) and 25 true-negatives (without evidence of ACL) with 5 false positive (were miss interpreted to have ACL) and 13 false negative (were not diagnosed clinically) (Table 2; Figure 3), which resulted in 83% sensitivity, 88.37% specificity…”

Again, if this discussion was over a much more severe grade 3 ACL rupture, with a 75% negative predictive value (which means that 1 in 4 ACL ruptures would go undetected by MRI-normal MRI read, but ACL rupture later detected), the idea that a knee MRI can infallibly diagnose a larger ACL tear is ridiculous.

What the sports medicine doctor seemed to miss in this patient, or at least was hesitant to entertain, is the concept of ligament laxity. The idea of sub-failure instability (that a ligament can be damaged to the extent that it doesn’t fail or rupture) is not new and dates back to at least the 1980s (4). This means that the shape of the stress-strain curve is changed, but the ligament remains intact. Let’s explore this idea.

Above is a diagram from a paper on the ACL ligament and tissue engineering (5). Note that if a ligament is stressed in its linear region, it can snap back and live to fight another day. However, if a ligament is stressed into the yielding and microfailure region, it undergoes microinjury. In that case, it can either heal itself or remain lax (grade 1-2 tear) with an altered stress-strain curve. Finally, a ligament can be loaded to catastrophic failure, which would be a complete rupture (grade 3).

As already discussed, orthopedic surgery to date has largely focused on ligaments that rupture. In fact, clinical exam tests like Lachman’s are focused on detecting that ligament state. IMHO, this is the paradigm that sports medicine doctor was using. This patient’s ACL was either so lax that it needed to be replaced, or it was normal, not considering the middle option of loose enough to cause her knee degenerative disease. In other words, the patient’s knee had been subtly unstable since the horse incident, and decades of use and micro-instability had chewed up the cartilage and meniscus in that joint.

Diagnosing Ligament Laxity is Still an Art

In modern medicine, we have severely de-emphasized the art of physical exam. That began with the advent of MRI and was pushed further out the door when managed care caused physicians to see more and more patients on any given clinic day. In this patient, her laxity could be found by looking at the rotational stability of the tibia side to side, as the ACL double-bundle morphology provides that type of stability. In her Lachman’s test, she had a “soft end feel,” meaning that one side gave more at its end range than the other. However, detecting this type of physical exam finding takes years of experience to master.

Detecting ACL laxity due to a grade 1 or 2 tear on MRI or physical exam is difficult (8):

“Clinical examination remains one of the most important steps when evaluating the injured knee. Ligamentous laxity is difﬁcult to quantify and is currently graded subjectively by the examiner (Noyes et al. 1991; Kuroda et al. 2012). Hole et al. found that clinical evaluation is unreliable in the differentiation of a 75 % sectioned ligament from a completely sectioned ligament (Holeet al. 1996).”

Chronic, partial grade 1-2 ACL tears, like the one found in this patient, are notoriously difficult to diagnose (9):

“A partial ACL tear can be observed in 10%–27% of isolated knee injuries.[3] Most patients are unable to comprehend the true nature of their knee morbidity as partial tears lack typical instability, presenting only with quadriceps atrophy on general examination and failure to return to do sports activities. No clinical test is sensitive enough to accurately diagnose a partial ACL tear. Various clinical tests have been advised, but all lack good sensitivity to fathom final diagnosis. The combination of more than one clinical examination helps in the identification of the bundle involved.”

“A partial ACL tear, however, is challenging to identify confidently on imaging.”

Again, the idea that two physicians with different training on this topic could get two different opinions on knee ligament laxity is very real.

Lachman’s Test and MRI

A Lachman’s test was used by the sports med doctor on this patient and is used to detect a grade 3 ACL rupture (which this patient did not have), so it would be the wrong test to look for this type of laxity in the ACL. However, even in that binary world (ruptured or not ruptured), the test, when used during a routine clinical exam, is no better than 50/50 with an average inter-rater reliability of 0.51 (0.15-0.87) (2). That means that 100 physicians could perform this test looking for an ACL rupture, and their assessments would agree no more than half the time. Even instruments designed to look for ACL laxity have high inter-rater reliability and only work reliability in studies when used by the same individual (higher intra-rater reliability) (3). Given that almost all of the physical exam tests that we use in daily practice have at best, moderate inter-rater reliability, you can see why physicians often disagree with what’s found on the physical exam.

Training Your Hands

When I first came out of residency, I was introduced to a local physical therapist, a manual medicine master. He had learned much of what he knew from old osteopaths well-versed in the art of physical exam. Back then, most students in osteopathic medical school were more interested in learning the latest and greatest allopathic medicine, so these osteopathic instructors often found that their DO students were turning up their noses to learning hands-on physical exam skills. In this PT, these old osteopaths found a willing vessel to teach and pass on these advanced manual skills. I was also willing to be trained as I thought it was all fascinating. As I began to take manual physical therapy courses with this PT, I went from being completely unable to use my MD-trained hands to detect things like instability to starting to understand that this was possible. It wasn’t until hundreds of patients and several years later that I became confident in finding unstable joints. In other words, without extensive specialized training, I would have never been able to detect this patient’s knee instability.

PRP Injections

Both the sports medicine doctor and I offered this patient a platelet-rich plasma (PRP) injection. The difference is that I began using PRP in 2005 when this physician was still an undergrad. The practical difference is that I have had almost two decades to observe where PRP is effective and where it fails. The sports med doctor is a recent adopter of PRP.

Every year I perform an analysis of the published PRP RCT literature. The latest 2024 edition shows 144 RCTs with 87% showing superiority or non-inferiority to the comparator. Each circle on this infographic represents an individual RCT (see https://regenexx.com/wp-content/uploads/2024/07/PRP-RCTs-Jul-2024-V2.pdf for a PDF with active links).

The clinical areas where PRP now has clinical RCT support include:

Knee OA
Knee meniscus tear
Hand OA and other conditions
Carpal tunnel syndrome
Hip OA
Hip tendinopathy
Shoulder OA, tendinopathy, and rotator cuff tear
Epicondylitis
Lumbar radiculopathy, facet syndrome, and DDD
SI joint pain
Achilles tendinopathy and partial tears
Ankle OA
Plantar fasciitis

In other words, based on the existing RCT data, PRP has been shown to be effective for use throughout the musculoskeletal system for a wide variety of diagnoses.

Focusing on partial tear ACL injuries, the following has been published on using PRP when injected into the joint (NOT into the ACL):

A successful retrospective observational study in 72 athletes with an 83% return to sports rate (no direct injection into the ACL, only intra-articular) (10).
A failed RCT in young athletes (no direct injection into the ACL, only intra-articular) (11).

The two opposing clinical outcomes in these studies make sense, as the ACL is surrounded by a sheath (also called a synovial invagination) (16). This means that injecting PRP intra-articular makes little common sense. Why? The PRP won’t be in direct contact with the ligament in a partial ACL tear.

This is what is published on direct injection of PRP into the ligament:

A case study showing MRI evidence of healing (12).
A case study of a mucoid ACL showing MRI evidence of healing (14).
A case series of 19 patients showing normalization of KT-1000 measured laxity in all treated cases with an 82% return to sports rate (13).
A case series of 42 patients showed a success rate of 90%, showing an objective reduction in laxity as measured by device and a 71% return to sport rate (15).

Hence, the current literature suggests that direct injection into the ACL would be one way to treat this problem. This is using a 25-gauge needle to inject PRP into the ligament once the placement has been confirmed on fluoroscopy. Back in 2015, I developed a direct injection technique into the ACL using fluoroscopic guidance. I have published three studies on selected partial and complete non-retracted ACL tears using orthobiologics and this technique (16-18). One of these is a mid-term analysis of an RCT with that data collection now complete and the final RCT being submitted for publication this month. That RCT data shows MRI evidence of healing of most of these ACLs with a precise injection of bone marrow concentrate plus PRP with high return to sport and low retear rates (about half of those reported for ACL surgery). This final RCT data should soon be published.

Training Physicians in These Techniques

In 2015, I founded a non-profit physician professional organization called the Interventional Orthobiologics Foundation. This organization was funded through a generous multi-million dollar grant from local billionaire John Malone. That group is dedicated to teaching physicians like this sports medicine doctor concepts like how to identify a mildly lax ligament on exam or how to inject an ACL ligament that has micro or a partial tear with PRP or other orthobiologics.

That curriculum I created, and that IOF has now updated, has trained 603 physicians, including dozens from academic medical centers, including Mayo Clinic, Stanford, U Penn, Yale, Vanderbilt, Emory, University of Michigan, University of Miami, University of Wisconsin, UCLA, UC Davis, Baylor, LSU, and the University of Colorado. This same concept is also now taught in courses given by many other organizations.

The upshot? If orthobiologics are going to recognize their full societal impact, physicians using them need to learn new skills. One of those is to stop calling ligaments “intact” based on an MRI report and a quick exam. IMHO, learning to identify lax ligaments and how to treat these areas will improve orthobiologic treatment outcomes. However, that can only happen if physicians who use orthobiologics are open to the idea that we must update the binary orthopedic surgical paradigm that sees ligaments as “ruptured” or “fine.”

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Evans J, Mabrouk A, Nielson Jl. Anterior Cruciate Ligament Knee Injury. [Updated 2023 Nov 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK499848/
Peeler J, Leiter J, MacDonald P. Accuracy and reliability of anterior cruciate ligament clinical examination in a multidisciplinary sports medicine setting. Clin J Sport Med. 2010 Mar;20(2):80-5. doi: 10.1097/JSM.0b013e3181ceca45. PMID: 20215888.
Runer A, Roberti di Sarsina T, Starke V, Iltchev A, Felmet G, Braun S, Fink C, Csapo R. The evaluation of Rolimeter, KLT, KiRA and KT-1000 arthrometer in healthy individuals shows acceptable intra-rater but poor inter-rater reliability in the measurement of anterior tibial knee translation. Knee Surg Sports Traumatol Arthrosc. 2021 Aug;29(8):2717-2726. doi: 10.1007/s00167-021-06540-9. Epub 2021 Mar 31. Erratum in: Knee Surg Sports Traumatol Arthrosc. 2022 Aug;30(8):2879. doi: 10.1007/s00167-021-06726-1. PMID: 33791824; PMCID: PMC8298217.
Provenzano PP, Heisey D, Hayashi K, Lakes R, Vanderby R Jr. Subfailure damage in ligament: a structural and cellular evaluation. J Appl Physiol (1985). 2002 Jan;92(1):362-71. doi: 10.1152/jappl.2002.92.1.362. PMID: 11744679.
Runer A, Roberti di Sarsina T, Starke V, Iltchev A, Felmet G, Braun S, Fink C, Csapo R. The evaluation of Rolimeter, KLT, KiRA and KT-1000 arthrometer in healthy individuals shows acceptable intra-rater but poor inter-rater reliability in the measurement of anterior tibial knee translation. Knee Surg Sports Traumatol Arthrosc. 2021 Aug;29(8):2717-2726. doi: 10.1007/s00167-021-06540-9. Epub 2021 Mar 31. Erratum in: Knee Surg Sports Traumatol Arthrosc. 2022 Aug;30(8):2879. doi: 10.1007/s00167-021-06726-1. PMID: 33791824; PMCID: PMC8298217.
Nau, Thomas & Teuschl-Woller, Andreas. (2020). Ligament Tissue Engineering: The Anterior Cruciate Ligament. 10.1007/978-3-030-18512-1_7-1.
Kostov H, Stojmenski S, Kostova E. Reliability Assessment of Arthroscopic Findings Versus MRI in ACL Injuries of the Knee. Acta Inform Med. 2014 Apr;22(2):111-4. doi: 10.5455/aim.2014.22.111-114. PMID: 24825936; PMCID: PMC4008041.
Ohashi, Bruno & Ward, James & Araujo, Paulo & Kfuri Jr, Mauricio & Pereira, Hélder & Espregueira-Mendes, Joao & Musahl, Volker. (2015). Partial Anterior Cruciate Ligament Ruptures: Knee Laxity Measurements and Pivot Shift. 10.1007/978-3-642-36569-0_85.
Chandra, Abhishek; Agarwal, Aakanksha1,; Azam, Md. Quamar. Demystifying Partial Tears of the Anterior Cruciate Ligament: A Review of Current Diagnostic and Management Strategies. Journal of Arthroscopy and Joint Surgery 10(1):p 1-9, Jan–Mar 2023. | DOI: 10.4103/jajs.jajs_126_22
Herdea A, Struta A, Derihaci RP, Ulici A, Costache A, Furtunescu F, Toma A, Charkaoui A. Efficiency of platelet-rich plasma therapy for healing sports injuries in young athletes. Exp Ther Med. 2022 Mar;23(3):215. doi: 10.3892/etm.2022.11139. Epub 2022 Jan 11. PMID: 35126718; PMCID: PMC8796279.
Zicaro JP, Garcia-Mansilla I, Zuain A, Yacuzzi C, Costa-Paz M. Has platelet-rich plasma any role in partial tears of the anterior cruciate ligament? Prospective comparative study. World J Orthop. 2021 Jun 18;12(6):423-432. doi: 10.5312/wjo.v12.i6.423. PMID: 34189080; PMCID: PMC8223727.
You CK, Chou CL, Wu WT, Hsu YC. Nonoperative Choice of Anterior Cruciate Ligament Partial Tear: Ultrasound-Guided Platelet-Rich Plasma Injection. J Med Ultrasound. 2019 Apr 10;27(3):148-150. doi: 10.4103/JMU.JMU_121_18. PMID: 31867179; PMCID: PMC6905270.
Seijas R, Ares O, Cuscó X, Alvarez P, Steinbacher G, Cugat R. Partial anterior cruciate ligament tears treated with intraligamentary plasma rich in growth factors. World J Orthop. 2014 Jul 18;5(3):373-8. doi: 10.5312/wjo.v5.i3.373. PMID: 25035842; PMCID: PMC4095032.
Seeto AH, Wilson MD, McMeniman M, Astori IP. Severe mucoid degeneration of the anterior cruciate ligament (ACL) treated with conservative arthroscopic debridement and platelet-rich plasma (PRP) injection. BMJ Case Rep. 2024 Feb 13;17(2):e257217. doi: 10.1136/bcr-2023-257217. PMID: 38350698; PMCID: PMC10868321.
Koch M, Mayr F, Achenbach L, Krutsch W, Lang S, Hilber F, Weber J, Pfeifer CG, Woehl R, Eichhorn J, Zellner J, Nerlich M, Angele P. Partial Anterior Cruciate Ligament Ruptures: Advantages by Intraligament Autologous Conditioned Plasma Injection and Healing Response Technique-Midterm Outcome Evaluation. Biomed Res Int. 2018 Jul 25;2018:3204869. doi: 10.1155/2018/3204869. PMID: 30148163; PMCID: PMC6083554.
Duthon VB, Barea C, Abrassart S, Fasel JH, Fritschy D, Ménétrey J. Anatomy of the anterior cruciate ligament. Knee Surg Sports Traumatol Arthrosc. 2006 Mar;14(3):204-13. doi: 10.1007/s00167-005-0679-9. Epub 2005 Oct 19. PMID: 16235056.
Centeno C, Lucas M, Stemoer I, Dodson E. IMAGE-GUIDED INJECTION OF ANTERIOR CRUCIATE LIGAMENT TEARS WITH AUTOLOGOUS BONE MARROW CONCENTRATE AND PLATELETS: MIDTERM ANALYSIS FROM A RANDOMIZED CONTROLLED TRIAL. Bio Ortho J Vol 3(1):e29–e39; October 5, 2021.
Centeno C, Markle J, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. J Transl Med. 2018 Sep 3;16(1):246. doi: 10.1186/s12967-018-1623-3. PMID: 30176875; PMCID: PMC6122476.
Centeno CJ, Pitts J, Al-Sayegh H, Freeman MD. Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. J Pain Res. 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. PMID: 26261424; PMCID: PMC4527573.
Moseley JB, O’Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259. PMID: 12110735.

Interventional Orthobiologics And Orthopedics Blog – Regenexx

My 2024 PRP RCT Infographic 2.0

I blog about what comes my way as a practicing physician using orthobiologics and the medical director of Regenexx. In many ways, LinkedIn becomes my professional sounding board with other physician colleagues. This past week, I posted my 2024 PRP RCT infographic, which was very well received. However, one colleague pointed out that I should have spent more time parsing non-inferior studies from those showing superiority for PRP. If you’re wondering what that means, don’t worry; you’re not alone. Let’s dive into that concept and an edited 2024 PRP infographic.

Why Is PRP a Game Changer?

Physicians who inject things precisely using imaging guidance into painful or damaged parts of the musculoskeletal system have inherited some severely flawed tools. One of those is corticosteroids. These medications were introduced in the 1940s after America helped win WWII. Hence, they are far older than any practicing physician using them today. In many cases, they are far older than the parents of physicians using them today.

Your body uses corticosteroids daily, but it uses nanograms of these substances. The problem is usually not the corticosteroid but the absurd milligram dose physicians use. How big a dose is a milligram of steroid? If the height of a matchbook is a nanogram, then the height of the Empire State Building is a milligram.

I first realized how crazy this dose was when we cultured mesenchymal stem cells in about 2006. I asked our lab staff to place a single drop of the corticosteroid we used in one of those cultures, which promptly killed all stem cells. What happens when you use a nanogram dose (which doctors don’t have ready access to)? You can push these cells to differentiate into one tissue over another, and they will stay quite healthy.

We have a mountain of evidence that these mega doses of corticosteroid used by doctors every day kill cartilage, destroy tendon cells, kill off bone osteoblasts, and wreak havoc with the immune and endocrine systems. As currently formulated, this is a bad drug class that probably needs expanded informed consent before it’s injected.

It’s in this context that we should be discussing the non-inferiority or superiority of PRP. For example, this means that if PRP is non-inferior to corticosteroids and we know that steroids are bad drugs hurting our patients, PRP clearly wins.

What the Heck Does Non-inferior Mean?

Every profession has words and phrases it creates that are overly complex, and non-inferior is one of those terms. This basically means that when you test one drug or treatment versus another, one drug/treatment works about as well as the other or is “non-inferior.” The drug or treatment we compare against another is called a “comparator”. Superior means that the tested drug/treatment is better than the comparator. Inferior goes the other direction. Hence, in our context this morning:

Superior-PRP is better than the comparator.
Non-inferior-PRP is about the same as the comparator
Inferior-PRP performed worse than the comparator

Reworking the 2024 Infographic

I spent the better part of a week going through the 144 entries in the 2024 PRP infographic one by one. As with any massive undertaking, I found a few errors and bad links that needed to be fixed. Often, these were double links with the correct one present and one copy/pasted from the old icon. All of that was fixed. The new 2.0 PRP infographic is below (the new one is also on the original post from July,9th). Please click the image below to be taken to the PDF with the active links.

I also coded every study with:

No standard of care comparator means that the study wasn’t about seeing if PRP worked better than [steroid, HA, saline, etc…], but instead something like does 1 PRP injection work better than three injections?

So what does this reworked data look like?

87% of PRP studies against standard-of-care comparators like steroids, HA, PT, needling, etc… were positive trials. That means they either showed that PRP was superior or non-inferior to the commonly used treatment comparator. For non-inferior, saline was excluded as that was a placebo. So, if PRP was the same as placebo, then the study was coded as a failure.

Above is superior vs. non-inferior vs. inferior, broken out into categories.

The upshot? It was great to go back through the original infographic study by study and tease all of this out. In addition, that gave me a chance to fix a few links and other things. Ultimately, my original recommendation that you now have my permission to roll on the floor laughing when someone says we don’t have enough research that PRP is effective still stands!

Interventional Orthobiologics And Orthopedics Blog – Regenexx

QC Kinetix Goes from Mastering the Upsell to Reducing Costs?

I have often written about QC Kinetix because they’re hard to miss. They have bombarded the airwaves across the US, causing countless physician colleagues to reach out and ask, “What the heck is this?” Now I hear that the company has decided to create a program to save corporations money on their elective orthopedic surgery spend. So, let’s jump in and see what’s up.

What is QC Kinetix?

QC Kinetix is a group that uses mid-levels (i.e., not physicians) to deliver orthobiologic injections and sets up shop in doctor’s offices when they are not being used. Most of their clinics are investor-owned rather than physician-owned. They get people in the door through aggressive radio advertising and then use aggressive sales techniques to “upsell” the patient and get them into the most expensive regen med option they often can’t afford. To close the deal, they often use “buy today for a discount” sales pressure with financing. Finally, they often hire “medical directors” who rarely visit the clinic. Do you think I used the term “aggressive” too aggressively above? That was purposeful as IMHO there is no other way to describe this operation.

Maybe I’m making all of this up? Mitch Sheinkop, the company’s new medical director, confirmed most of it in an interview. Other issues that Dr. Sheinkop mentioned were the severe drop in quality between the corporate-owned clinics (only 6 of them) and the franchise clinics (almost 200 of them). I have also had a QC insider reach out to me personally and he or she confirmed that everything I have written about this company was accurate.

As you might imagine, all of this has legit physicians involved in working hard to help patients with orthobiologics concerned. Why? They spend tens of thousands of dollars each year learning the latest and greatest techniques at conferences and spend many hours honing their skills only to see a mid-level PA with feeble supervision and far fewer skills claim that they can offer the same services. They are appalled by the upsell at these clinics and the sky-high bills for lesser quality care. They know all this because the smart patients leave the QC Kinetix hard sell and eventually wander into their clinics.

The Class Action Suit

Because of what IMHO is a classic oversell and underdeliver operation, QC Kinetix has an active class action suit against the company. From the lawsuit:

“The complaint claims that during the women’s appointment later that month, “QC Franchise Group did not take any images, include [sic] x-rays, MRI’s or CAT Scans, nor did it review any of Plaintiff’s prior medical records regarding the cause of her pain.” The plaintiff also claims that she did not see a medical doctor at any point at QC Kinetix – Champaign.

According to the case, the woman was then subjected to a “high-pressure sales presentation” pushing her to get injections in both hips and both shoulders, even though the plaintiff was not having pain on both sides and her pain originated from nerves in the lower back. The plaintiff says she was eventually convinced to agree to undergo five treatment sessions that would cost a total of $20,000.”

“Per the complaint, the plaintiff agreed to pay for the treatment with a $20,000 loan serviced by defendants Security First Bank and Med-Den Funding, LLC, which does business as Proceed Finance. The case claims that the loan documents the plaintiff received contained a notice representing that any loan cancellations must be initiated through the medical provider and that it would be up to the medical provider to decide whether any refund would be made or claims honored.”

The QC Kinetix Corporate Program

If you read this blog, you know I often write about what I experience daily. This week, a colleague sent a presentation showing that QC Kinetix is trying to sell a corporate program. This means they suggest that companies use QC Kinetix sites to save money. I have to say that I laughed a bit, as, IMHO, that’s like putting a gambling addict in charge of your checking account. Everything that QC Kinetix has shown the medical world to date goes contrary to the idea that it could ever hold a credible fiduciary position with an employer. Let’s dive into what we do at Regenexx to better understand how silly this is.

The Regenexx Corporate Program

The Regenexx Corporate program is now 2,200 employers strong. All indications are that the number of covered lives in that program will double over the next 12 months. So what is it?

Regenexx Corporate signs contracts with medium- and large-sized employers with self-funded health plans. That means these companies pay the bills for employee medical care rather than going through a third-party insurer like most small companies. This makes sense, as why would you let an insurance company make money off of premiums if you didn’t have to? Since these companies are self-funded, they have tremendous control over what they cover.

Regenexx Corporate then refers patients to our 100+ US sites when the employee is considering surgery. A real doctor (not a PA) in a real full time medical clinic run by doctors, then decides whether a Regenexx image-guided orthobiologic injection procedure would save the employee downtime and the employer money. Regenexx has a strict utilization review over this whole process, meaning if, based on our almost two decades of collected data, that procedure won’t save the employer money; the procedure isn’t covered under the program. If approved, that employee can have their orthobiologic procedure paid through their health plan. In our experience, allowing free rien on orthobiologics in a health plan is a prescription that costs the employer more money than surgery, not less.

In addition, knowing which procedure in which clinical setting will be effective and which procedure will likely fail is critical. The only way that Regenexx knows that is through the two decades of registry data we have collected and dozens of peer-reviewed publications. QC Kinetix would have no way of knowing which end is up in this department.

Let’s take an example. A patient with moderate to severe hip arthritis goes to a Regenexx clinic to try to avoid surgery. Since our registry data shows a low chance of success for this procedure, even if we use bone marrow concentrate containing stem cells, the Regenexx corporate program won’t approve this procedure. That information on the high failure rate for more severe hip arthritis comes from almost two decades of data collection across thousands of patients and a published case series (1). On the other hand, the same patient with moderate to severe knee arthritis is a candidate because the outcomes are better in that clinical scenario. That data comes from our registry, thousands of patients over almost two decades, several published case series, and a randomized controlled trial (2-6). In addition, a QALY cost analysis. Does QC Kinetix have any of this data collected, analyzed, or published? Nope.

I have included a table above to compare and contrast Regenexx corporate and QC Kinetix.

The upshot? IMHO, I think it’s hilarious that a company that has aggressively been selling people treatments they don’t need and often can’t afford is now claiming to be able to save anybody money. I would be surprised if QC is still in business in 24 months, let alone a player in delivering orthopedic cost savings to employers.

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References:

(1) Centeno C et al. Efficacy and Safety of Bone Marrow Concentrate for Osteoarthritis of the Hip; Treatment Registry Results for 196 Patients. Journal of Stem Cell Research and Therapy. 2014, 4:10

(2) Centeno CJ, Berger DR, Money BT, Dodson E, Urbanek CW, Steinmetz NJ. Percutaneous autologous bone marrow concentrate for knee osteoarthritis: patient-reported outcomes and progenitor cell content. Int Orthop. 2022 Oct;46(10):2219-2228. doi: 10.1007/s00264-022-05524-9. Epub 2022 Aug 6. PMID: 35932306; PMCID: PMC9492580.

(3) Centeno CJ, Money BT, Dodson E, Stemper I, Steinmetz NJ. The rate of venous thromboembolism after knee bone marrow concentrate procedures: should we anticoagulate? Int Orthop. 2022 Oct;46(10):2213-2218. doi: 10.1007/s00264-022-05500-3. Epub 2022 Jul 18. PMID: 35844014; PMCID: PMC9492566.

(4) Centeno C, Cartier C, Stemper I, Dodson E, Freeman M, Azuike U, Williams C, Hyzy M, Silva O, Steinmetz N. The Treatment of Bone Marrow Lesions Associated with Advanced Knee Osteoarthritis: Comparing Intraosseous and Intraarticular Injections with Bone Marrow Concentrate and Platelet Products. Pain Physician. 2021 May;24(3):E279-E288. PMID: 33988949.

(5) Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30. Erratum in: Int Orthop. 2018 Jan;42(1):223. doi: 10.1007/s00264-017-3680-2. PMID: 27026621.

(6) Centeno C, Pitts J, Al-Sayegh H, Freeman M. Efficacy of autologous bone marrow concentrate for knee osteoarthritis with and without adipose graft. Biomed Res Int. 2014;2014:370621. doi: 10.1155/2014/370621. Epub 2014 Sep 7. PMID: 25276781; PMCID: PMC4170694.

Interventional Orthobiologics And Orthopedics Blog – Regenexx

My 2024 PRP RCT Infographic

[A companion analysis to this blog was posted after this piece was published and can be seen here.]

Every year, I perform a deep dive into the orthobiologic literature to see what’s been published. This is part of my job as CMO of Regenexx, and it’s also a great opportunity to produce an infographic that others in the orthobiologics community can use. This is my 2024 edition of the PRP randomized controlled trials literature, which adds another several dozen studies over 2023. Let’s dive in.

Past PRP Infographics

I’ve been at this PRP infographics creation gig since 2019. That’s because 2018 was a banner year for PRP RCTs as this was when the clinical science behind PRP began to coalesce and mature. Here are my past infographics:

My 2024 Infographic

By my count, in the far too early, pre-dawn hours of Tuesday morning, there are now 144 PRP RCTs. Only 17 show that PRP is inferior to the comparator, and as I have previously reported, most of those studies never used real PRP (at least 2X concentrated platelets). 9 studies weren’t about a standard of care comparator. So, even if you include the fake PRP studies, that’s an RCT failure rate against a standard of care comparator of 13%.

It’s insane to think we have 127 successful PRP RCTs as of the summer of 2024. Knowing the orthopedic surgery RCT against sham/placebo literature well, more RCTs support PRP use than exist in the entire field of orthopedic surgery. The surgeons reading this right now may be yelling at the screen because they see orthopedic surgery RCTs published all the time. However, 99% of those are for surgery or device X versus surgery or device Y, not whether surgery X or Y is better than placebo, sham, or physical therapy.

This year, several dozen new studies and an entire section on plantar fasciitis were added. Of note is that the PRP spine literature has picked up, and we’re still seeing new knee OA RCTs published.

How to Use This Infographic

Click on the image above to see the PDF. Each circle links to a PubMed abstract or full-text article. Red circles are trial failures where PRP was inferior to the comparator. If you know of studies I have missed that are listed in Pubmed, please write to me at my office email, which is centenooffice@centenoschultz.com. If you find any bad or broken links, please let me know. If you want to use this document for a lecture or physician educational purposes (not patient marketing), that’s fine; just let me know by sending me an email. I produce these infographics to get the word out to other physicians and policymakers.

The upshot? If anybody says we don’t have enough published data on PRP yet, you can now officially break out laughing and begin rolling on the floor. While more research is always welcomed, we have more basic efficacy data on PRP than on the entire field of orthopedic surgery. Everyone using PRP daily in patients should be very proud of that fact!

[This blog was updated on 7/17/24 with an edited infographic. Several bad links were cleaned up, and additional information was added.]

Pages

Friday, October 11, 2024

Sunday, October 6, 2024

Sunday, September 8, 2024

Overview of Knee Replacement

The Cost of Knee Replacement Surgery

Factors Contributing to Loosening of Knee Replacement

7 Common Loosening Knee Replacement Symptoms To Know

1. Pain Ranging from Mild to Severe

2. Swelling and Redness

3. Popping or Clicking Sound

4. Joint Stiffness

5. Skin Discoloration

6. Instability

7. Reduced Range of Motion

How Medical Specialists Diagnose a Loosened Knee Prosthesis

Is Surgical Intervention Needed to Correct Loosening?

Potential Risks of Revision Surgery

Surgical Issues

Infection

Poor Wound Healing

Bone Fracture

Blood Vessel Issues

Circulatory Problems

Nerve Damage

Improve Mobility Without Surgery If A Knee Replacement Fails

Defining the Anatomy of the Knee

What Is Bursitis of the Knee?

Different Types of Bursitis of the Knee

Identifying the Signs and Symptoms

Pain and Tenderness

Localized Knee Swelling

Warmth Around the Knee

Causes of Bursitis of the Knee

Repetitive Irritation

Injury and Trauma

Bacterial Infection

Low Back Issues

Other Underlying Medical Conditions

Understanding the Vulnerable or At-Risk Groups

Potential Complications of Untreated Knee Problems

Diagnosing Bursitis of the Knee

Conventional Treatment Approaches to Bursitis of the Knee

At-Home Relief

Over-the-Counter/Prescribed Medications

Surgical Interventions

Why Choose a Non-Surgical Approach for Knee Health Care?

How Physicians In The Regenexx Network Approach Knee Conditions

Regenexx-SD

Regenexx-SCP

Regenexx-PL

Prognosis of Knee Bursitis

Slowing Down on Long-Form Blogs

My Sabatticals

Our Upcoming Journey

DIY vs. Chartering

Following Our Trip

What the Heck is mVASC?

Using mVASC for Knee OA?

Other mVASC Research

PRP Much?

MFat?

Safety

Regulatory

Orthobiologics and Dose

Bone Marrow Concentrate Dosing

CFU-f

CD-271

BMC Counts at the Bedside-TNCC

The New Research

What We Know Now About TNCC, BMC, and Knee OA

Final Dosing Recommendations

Our Scrolling World

Figuring Out How to Boil Down Complex Science to 10 Seconds

How to Get Your Morning Orthobiologics Update?

The Controversy

The Patient

The Traditional Orthopedic Surgery Approach

Ligament Laxity (sub-failure) vs. Ligament Rupture

Diagnosing Ligament Laxity is Still an Art