YOUR COMPLETE GUIDE TO
Non-Surgical Regenerative Orthopedics
Everything you need to know about non-surgical alternatives to orthopedic surgery.
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Table of Contents
Change Is Necessary
We need a change in the traditional approach to orthopedics and pain management. There is an epidemic of chronic pain in this country as 126 million people have suffered from some sort of pain in the last three months. Of that 126 million, 40 million people have pain every day and 20 million have pain that is severe enough to limit their activities and/or ability to work.
Until recently, standard treatments for musculoskeletal injuries to joints, tendons, ligaments, muscle, and bone have been focused on opioid narcotics, anti-inflammatory drugs (NSAIDS), cortisone injections, ablation (burning) of nerves, and surgeries. Regrettably, these mainstay strategies are fraught with potentially serious adverse effects, generally have mediocre results, and in many cases, can even worsen the problem.
- Narcotics are addictive and drug overdose deaths have been increasing at an alarming rate.
- Both cortisone and NSAIDS can accelerate cartilage loss in a joint.
- NSAIDS also increase the risk of gastrointestinal bleeding, kidney failure, heart attack, and stroke.
- Cortisone elevates sugar levels, increases risk of infection, and is quite potent at further degenerating already weakened tissue.
- Common surgeries for knee meniscus tears increase degeneration and the likelihood of a joint replacement in the future.
- Surgeries to repair torn knee ACL’s may result in more severe arthritis in the future.
- Joint replacements carry serious risks such as heart attack, stroke, clotting, and infection.
- Lumbar fusions for low back pain are often ineffective according to the most recent research and create new problems above and below the fused segments.
There is a desperate need for new, better, and safer strategies. This is where interventional non-surgical regenerative orthopedics comes into play.
What Is Interventional Non-surgical Regenerative Orthopedics?
Interventional non-surgical regenerative orthopedics is an innovative, natural, and highly successful alternative to common medical approaches to conditions that would otherwise require surgery. This exciting field opens up opportunities to address orthopedic or musculoskeletal injuries, arthritis, and other degenerative conditions by using a tissue preservation strategy that uses the body’s own healing cells to help restore more normal function to the human body. Regenerative orthopedic procedures encourage your body to actually heal itself and strengthen the damaged tissue. Advanced treatment protocols concentrate your own platelets, growth factors, and bone marrow and deliver them precisely (under image guidance) into the site of your injury to support and promote natural healing.
Our founder, Dr. James Leiber, joined Dr. Josh Axe on the Dr. Axe Show to discuss relieving pain and increasing function with bone marrow concentrate and PRP. Learn more about these healing modalities and hear how Dr. Axe and his wife have personally experienced relief from Dr. Leiber’s treatment in this informative video.
Who Is Regenexx?
Regenexx offers the world’s most advanced protocols and training in these non-surgical treatments of common orthopedic injuries and degenerative conditions. In 2005, Regenexx physicians were the first in the United States to inject bone marrow concentrate into orthopedic tissue. Regenexx procedures have remained the gold standard in non-surgical regenerative treatments. Regenexx provides custom solutions backed by extensive published research. All patients are tracked by a team of researchers for safety and outcomes as part of the largest database registry in the world for these types of procedures.
More than 131,600+ procedures have been performed as of 2021 and this number continues to increase daily. Today, Regenexx is the world’s largest, cohesive physician group dedicated to practicing advanced bone marrow concentrate and platelet orthobiologics. Fortune 500 companies and many other self-insured companies have seen the value of Regenexx, offering these procedures as a covered benefit and a preferred treatment strategy for their employees with musculoskeletal conditions. These companies are seeing cost-savings of 75% over traditional medical approaches and patient/employee satisfaction of greater than 95%.
Regenexx Tampa Bay physicians are amongst the world leaders in this field and are long-standing partners with Regenexx. In 2020, Regenexx Tampa Bay received the award for best patient outcomes and the most experienced based on total number of procedures amongst all the numerous sites.
Interventional (Non-surgical) Regenerative Orthopedics can be complex to explain. Let’s break down each aspect of our protocols so that you can better understand our methods.
“Orthobiologics” is the term used for the liquid solutions that are injected directly into damaged musculoskeletal tissue. These materials are typically made from substances that are naturally found in your body and are used to help injuries such as broken bones, injured muscles, tendons, and ligaments strengthen and heal.
Our bodies are designed to repair damage. Unfortunately, various external and internal factors can get in the way of our body’s ability to completely heal an injury. Regenexx orthobiologic treatments use your body’s natural healing agents to repair or mitigate damage by concentrating and focusing them at the precise site of your injury or pain. This approach allows for natural, efficacious healing without the need for surgery. In short, these procedures help overcome whatever barrier or threshold is needed to complete the repair process.
Our bone marrow contains stem cells, which are incredibly powerful and play many roles. For example, these cells can turn into other types of cells and release substances that orchestrate a repair response.
Stem cells work as our body’s primary means of repairing damage. Mesenchymal stem cells (MSC) live in high concentration in bone marrow, fat tissue, and in smaller concentrations plastered to blood vessels throughout the body. We prefer to use bone marrow concentrate since much of the research supports that MSCs derived from this source is the most effective for repair of orthopedic tissue. Additionally, the use of bone marrow concentrate that is minimally manipulated and used in the same patient from which it was taken is exempt from FDA regulations. That is, its use is considered to be just part of the same “surgical” procedure and thereby doesn’t require FDA approval, as opposed to stem cells derived from fat tissue or stem cells that are culture expanded (grown) from any source, which does require FDA drug approval. These bone marrowderived cells are drawn from the back of the pelvis and have the capacity to turn into bone, muscles, tendons, ligaments, and in a limited way, cartilage. After the cells are drawn, they are concentrated to derive 5-20 times more cells per unit volume when compared to a bedside centrifuge machine that the majority of physicians outside of Regenexx use. The bone marrow concentrate solution is then injected using precise image guidance (both live ultrasound and x-ray) into injured or weak tissue to rebuild, repair, or mitigate the effects of the injury. When performed in a skilled way, this procedure will improve the quality of the tissue and help the joint become more stable, less inflamed, and more functional. Our extensive research protocols using bone marrow have shown excellent outcomes in treating most orthopedic injuries. We believe that at least 70% of all orthopedic surgeries can be replaced with this less invasive, safer strategy.
“My surgery for a lumbar spine fusion was scheduled and I was dragging my right leg due to an accident…then I found Regenexx. I had PRP on my lower back in February of 2017. By July I was playing pickleball and riding my mountain bike. After that, I also had the same-day stem cell procedure on my wrist due to an old injury that had turned into arthritis and limited me significantly. Twelve months later I am back throwing the football with my grandson”
Culture Expanded Bone Marrow Concentrate
We practice the culture expansion (growth) of MSCs into larger quantities at our affiliated licensed site in Grand Cayman. This technology is used in select patients who have more severe orthopedic conditions, patients who want to treat multiple joints, and/or for patients who want to store and save cells for future treatments (stored at their current age). This procedure is not U.S. FDA-approved, but is the subject of an FDA-approved phase 2 clinical trial and is permitted in Grand Cayman as the practice of medicine. A small number of Regenexx physicians (us included) are licensed to practice in the Cayman Islands and perform this advanced treatment.
In some cases, adipose fat cells can be used effectively as a part of a larger treatment plan for orthopedic injuries to create a fat graft that supports and holds in place other structures allowing them to heal appropriately. Adipose tissue (obtained via mini-liposuction in the buttock area) that has been “minimally manipulated” (often referred to as microfragmented fat) can be used as an adjunct or a standalone injectable material for cushion or support. One study found that using fat in this way was equivalent in terms of clinical outcomes to using concentrated bone marrow for patients with knee arthritis. But, to be clear, this is NOT really a “stem cell” procedure.
Platelet-rich plasma (PRP) is created by concentrating the platelets in your blood to enhance healing. These platelets have growth factors that can jump-start your normal healing process and encourage your body to heal itself. Our proprietary lab processing allows us to create customized and individualized products based on your unique issues to maximize the repair process. We refer to Regenexx PRP as SCP (super concentrated platelets). The difference between Regenexx’s PRP and most other PRP is visible. Standard fare PRP is reddish in color because it still contains a significant number of red blood cells. Regenexx’s PRP is amber in color due removal of the harmful red blood cells and also due to its higher concentration of growth factors that can be customized from 2-40 or more times above what a basic centrifuge machine can produce. Our outcomes have demonstrated that this super-concentrated PRP produces better tissue healing in tendon injuries and better stimulation of the local stem cells to promote healing.
“I want to offer your team of professional staff and most particularly, to esteemed Dr. Leiber, my profound and most sincere gratitude. It is from your services and caring that I am now finding my pathway to a new lease on wellness. Dr. Leiber’s outstanding and impeccable knowledge and gifts of stimulating self-healing have been the spark to ignite my body’s much hoped for self-repair and renewal abilities. I am indebted to your services and look forward to upcoming and all future treatments!”
Platelet lysate is a highly specialized derivative of PRP. Normal PRP isolates platelets from the blood while slowly releasing growth factors into the site of the injury over the course of approximately one week. Our research shows that in some cases, a faster, more intense release of healing factors creates an improved healing response. By stripping all of the growth factors from platelets and making them available for immediate use, platelet lysate accomplishes this goal. As we have learned better ways to encourage the fast release of growth factors over the years, Regenexx’s proprietary platelet-lysate processing technology is now on its fifth generation. There are times we combine Platelet Lysate with SCP to get both a fast and slow release of growth factors at the same time.
While there is not nearly as much long-term research regarding cytokines, the initial results are promising. Regenexx uses Alpha 2 Macroglobulin (A2M), a cytokine that reduces inflammation and removes from tissues certain chemicals that have been shown to be destructive to cartilage. A2M is derived from a different part of your blood than PRP and shows tremendous promise as a means of treating or preventing osteoarthritis. Regenexx continues to lead the way in researching new ways to better use the body’s natural healing agents to treat orthopedic injuries.
Extra-cellular Matrix (ECM)
An extra-cellular matrix is best described as a scaffold on which cells that are attracted can grow. We use an ECM that is derived from an amniotic membrane that contains proteins and growth factors. We believe that this matrix can help orthobiologics in certain clinical scenarios such as tendon repair. It should be noted that the amniotic ECM product is NOT a stem cell procedure. This is commonly fraudulently advertised as a stem cell product by providers outside of the Regenexx network. No living stem cells are found in these products and either way (if they did or did not contain living stem cells), they would be required to obtain FDA approval to be used for injections of orthopedic tissue – which has yet to occur except for one product at this time. The product we use is called Amniofix, derived from otherwise discarded dehydrated human amnion/chorion membrane donated from live birth C-Sections (no fetus is harmed) which has been granted Regenerative Medicine Advanced Therapy (RMAT) by the FDA designation for use in the treatment of Osteoarthritis (OA) of the knee.
Why Non-surgical Regenerative Orthopedics Is The Best Alternative To Surgery
The Benefits of Regenexx Bone Marrow Concentrate and PRP Therapy
ExpertiseRegenexx selects physicians through a competitive and selective process. Only highly trained musculoskeletal specialist physicians are considered for entry into the Regenexx network. After approval, the physician must receive further training on image-guided precision techniques through the Interventional Orthopedic Foundation’s intense multi-level curriculum before being certified to perform Regenexx procedures for any given body area. Our physicians are senior level faculty for training other Regenexx and non-Regenexx physicians throughout the world.
QualityNot all regenerative products are created equally. Every Regenexx location has an on-site orthobiologics lab to generate superior substances. Our proprietary lab-processing techniques allow us to achieve much higher concentrations of cells than can be achieved with a typical bedside centrifuge. On-site lab processing allows us to create custom individualized orthobiologic solutions from your cells to treat your specific injury in order to achieve the best results. Precision Precise image guidance allows us to target the exact location of an injury. The importance of this can not be overstated. This meticulousness allows for far more consistent and sophisticated treatments that are safer with better clinical outcomes than would be available without image guidance.
Minimal RiskThese needle-based techniques are the foundation of a tissue preservation strategy that strengthens tissue and avoids the side effects of surgical procedures which involve cutting, scraping, burning, and removing tissue. It’s high finesse, lower risk, and eliminates the risk of developing scar tissue.
Minimal downtimeRecovery from an Interventional Orthopedic procedure is much quicker than a surgery and allows you to get back on your feet, back to work, and back to the activities you love faster.
Proven resultsPatient outcome data
Overview of Our Bone Marrow Concentrate and PRP Procedures
Regenexx procedures are the world’s most advanced bone marrow concentrate and blood platelet procedures for treating orthopedic injuries, arthritis, and other degenerative conditions. Before, during, and after your procedure, our exceptional staff works to provide a comfortable, personalized experience to each of our patients to determine the best course of action and help facilitate the entire healing process
The first step in this process is to schedule and attend a New Patient Evaluation. This is an hour-long personalized consultation with one of our physicians. During this evaluation, our goal is to ensure that we fully understand what you are experiencing and so that you can make an informed decision regarding your treatment.
“When I came to see Regenexx Tampa Bay, I was so upset that none of my previous doctors could come up with any solution that might help me to become more mobile again and decrease my pain level. When I came for my first appointment, I was met with respect, concern, and possibilities. Between the stem cell procedure and several platelet procedures in both legs, I am fully functional and, for the first time in 2.5 years, I was able to travel once again to Honduras (in 95-degree heat, on my feet 8 hours a day and loving over 200 children a day.)”
Regenexx SD Procedure
The Regenexx bone marrow concentrate protocol is called a same-day procedure because the cells are harvested and reinjected on the same day. For most patients, however, the recommended protocol is a series of injections of different orthobiologics that happens over the course of about a week depending on each unique situation. These injections include a prolotherapy pre-injection, the same-day bone marrow aspiration and re-injection procedure, and a blood draw and post-injection of multiple Regenexx’s proprietary platelet-rich plasma concentrations. This process applies to procedures for the knee, hip, shoulder, hand, wrist, foot, ankle, elbow, and spine though there are times where we will recommend only the same-day bone marrow aspiration and reinjection procedure without the pre- or post-injections.
- First Appointment (Pre-injection) – Your first visit involves an injection of a special hypertonic dextrose solution that creates a mild inflammatory environment that is conducive to healing. The purpose of this part of the procedure is to cause the same kind of acute inflammation that might occur during an injury. The pre-injection initiates your body’s own healing process and prepares your joints for the reinjection of your bone marrow concentrate. To use a farming metaphor, this step is like tilling the soil. This first visit will take approximately 30 minutes.
- Second Appointment (Bone Marrow Aspiration (BMA) – This appointment will last approximately 40 minutes. During this procedure, you will lie on your stomach on the procedure table where a local anesthetic will be applied. The physician will then draw bone marrow from the back of your iliac crest using precise image guidance. The doctor will usually draw the marrow from the back of the pelvis on both sides. Some patients will be given an oral sedative and pain medication to help to ease anxiety, relax the muscles, and dampen the pain prior to the bone marrow draw. The bone marrow aspiration process is often described by patients as being only mildly uncomfortable and is typically well tolerated. It is essential to fast (no food or caffeine; water only) for 3 hours prior to this procedure.
- Third Appointment (Re-injection) – This is the second injection in a series of three and typically takes 1 – 2 hours. Your re-injection appointment will take place approximately 2 – 5 days after your pre-injection and takes place between three and eight hours after the bone marrow aspiration. Local anesthesia is used to numb the area being treated. If we are treating an extremity (shoulder, elbow, knee, ankle, foot), you may be offered a nerve block. Your bone marrow concentrate will be injected using real-time imaging guidance (ultrasound and/or fluoroscopy) to ensure your cells are injected precisely where needed. To continue the farming metaphor, this step is like planting the seeds.
- Fourth Appointment (Blood Draw) – The blood draw is scheduled for the morning of your post-injection and takes approximately 15-20 minutes. The blood is used to prepare your post-injection.
- Fifth Appointment (Post-injection) – This is your final injection in a series of three and will take about 15-30 minutes. The postinjection appointment takes place 2 – 5 days after the re-injection. The post-injection is a combination of super-concentrated platelets (SCP) and platelet lysate (PLM), which are derived from your own blood. It is processed in our on-site orthobiologics lab by a skilled technician who can include more of the blood components that encourage and support healing while removing other components that cause unnecessary inflammation and discomfort. These growth factors aid and stimulate the re-injected cells to enhance the healing process. Local anesthesia is used to numb the area being treated. This would be like watering or fertilizing the seeds.
- Post-Procedure – The bone marrow concentrate injection produces a micro-injury in the joint. As a result, expect the joint to be sore for two to three days. Your physician may prescribe pain medicines that will not hinder the healing caused by the procedure. Patients can additionally take Tylenol but are asked to avoid NSAIDs. The goal is to allow the cells to attach and then to protect them while they promote healing and strengthening of various tissues. Do not take a bath for three days, but a shower 12 hours after the procedure is fine. For the first few days after, you should limit activity on the joint. Wear all recommended braces or boots. Most patients report a modest improvement in 6 to 8 weeks. You will notice that as time goes on your pain that occurred before is less severe and frequent. Most patients are able to resume light activities after 5 to 7 days. Usually, at 6 to 8 weeks, patients begin to resume a more vigorous exercise schedule. Most of our very active patients are able to return to their regular routine in about 6 weeks and push their performance to higher levels in 8 to 12 weeks. Improvements will continue throughout this time period. Most patients notice continued healing over many months. Our outcome data suggests peaking at 1 to 2 years out. Results vary by patient and depend on the condition of the area treated, age, and general health.
For most patients, the recommended SCP or PL protocol involves a blood draw and an injection on the same day. This process applies to procedures for the spine, knee, hip, shoulder, hand, wrist, foot, ankle, and elbow. Also, Platelet Lysate is often recommended for back and spine treatments that include injections around nerves in the epidural space.
Procedure Day – On your procedure day, blood is drawn from a vein in your arm typically in the morning. This blood is then processed and prepared in our lab for re-injection within 24 hours. We use this blood to prepare an injection of highly concentrated platelet-rich plasma containing the growth factors isolated from your blood. This procedure takes approximately 30 min to 1.5 hours, depending on the body region and issue being treated. During your second appointment of the day, this platelet-rich plasma is injected under precise image guidance into the treatment site. Local anesthesia is used to numb the area being treated. If we are treating an extremity (shoulder, elbow, knee, ankle, foot), you may be offered a nerve block.
Post-Procedure – We suggest moving the joint around gently multiple times within hours after the injections to disperse the platelet-derived injection or prolotherapy throughout the tissues. This seems to decrease the amount and duration of pain from the injections. Also, avoid excessive activity in the hours after injection. Anticipate moderate to significantly increased pain and stiffness for the first 2 to 3 days following your procedure as the Regenexx SCP and PL injections also produce a micro-injury in the joint. Your physician may prescribe pain medicines that will not hinder the healing caused by the procedure. Patients can additionally take Tylenol, but are asked to avoid NSAIDs. You may have swelling in the treated joint(s). After this short period of time, we anticipate a gradual decrease in soreness and return to baseline over a period of 1 to 2 weeks. We suggest waiting 6 to 8 weeks before returning to full-strength activities unless instructed otherwise by your physician.
In general, we always try to look at more than one injured part. As a result, it’s very likely we will recommend other types of conservative care to restore normal biomechanics. This might include physical therapy, different types of myofascial release, or specific home exercises. Our physicians work with professional therapists who have years of experience in understanding the needs of a regenerative medicine patient.
Note » Results typically become apparent over 1-3 months but sometimes can take as long as 6-9 months.
We understand that you want to get back to normal as soon as possible. All of our procedures are designed to promote as much early activity as possible. Here is a general guide to when you can return to normal activity:
- Bone healing procedure (for fracture nonunion or avascular necrosis) You must be off the area on crutches until the pain from the procedure subsides. You can then move toward slowing increasing activities over the next few weeks. Total time off the area for most patients is 1-3 weeks with returning to normal activities at about 6 weeks. The only exception is when there is an existing rod or plate stabilizing the fracture site, in these cases you will be allowed more activity more quickly.
- Joint procedure For joints with cartilage loss, low impact activities would be encouraged within one week after the procedure. Full high impact activities would be expected to return at 6-8 weeks.
- Partial tendon/ligament/muscle tear Low impact activities would be encouraged immediately after the procedure. Full high impact activities would be expected at approximately 6-12 weeks.
Note » Some of our patients will require a second or even third procedure. Our usual protocol involves 1-3 injection cycles, but the majority of our patients get a single procedure.
Our complications to date have been in the mild to moderate category and rare (using the HHS OHRP guidelines for complications reporting). This categorization means that either the complication (i.e. transient swelling) required no medical treatment (mild), or if it did require medical treatment, the treatment was simple. Regenexx has published the world’s largest safety and complications tracking study to date of bone marrow concentrate use in patients. This study did not show any serious complications and did not show that any patient developed cancer related to the procedure. In our opinion, infection is the most dangerous complication, but Regenexx has the longest safety profile in the market and we always take proper precautions to prevent this during our procedures.
Areas That Can Be Treated
Regenexx procedures can strengthen and improve damage to bone, muscle, cartilage, tendons, ligaments, and some nerves throughout your body. Our customized procedure protocols use your body’s own healing agents to strengthen and improve the health of injured orthopedic tissue without surgery, thereby decreasing pain and helping improve function so that you can return to the things you love to do.
Is Interventional Non-surgical Regenerative Orthopedics Right For Me?
It almost always makes sense to start with a less invasive and safer approach to a chronic, non-life threatening orthopedic pain-related condition. Anyone, at any age can be a candidate for a Regenexx procedure as long as they have an orthopedic condition that is keeping them from doing the activities they want to do. The likelihood of success will vary to some extent based on age, the severity of the condition, general health, other medical conditions, medications, nutrition, environmental chemical exposure, sleep, stress, etc. Even in situations where certain factors may decrease your likelihood of a positive outcome (such as chronic use of certain medications that interfere with healing such as prednisone), there may be options and advice that the doctor can provide to improve your chances to the point that it would be worth a try. This is why it is so important to have a thorough consultation with one of our physicians to look at your specific situation and provide you with an individualized and collaborative recommended plan of care.
Regenexx® at New Regeneration Orthopedics
Regenexx® at New Regeneration Orthopedics is Florida’s premier and most experienced non-surgical regenerative medicine center. We are proud to offer the nation’s most advanced bone marrow concentrate procedures for injuries and arthritis. We also perform Sonex micro-invasive carpal tunnel release procedures, as well as Tenex Health TX, a minimally invasive procedure used to treat chronic tendon and plantar fascia disease at its source as well as a way to remove bone spurs and calcifications. Our procedures increase function, decrease pain, and offer the patient viable alternatives to invasive surgery typically followed by lengthy periods of downtime and painful rehabilitation. Interventional regenerative orthopedics is our primary focus.
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