Oct 27, 2016
I recently received the yearly publication from the Orthopedic and Rheumatology Institute of the Cleveland Clinic; the latter recognized as one of the 10 most prestigious orthopedic centers in the nation. Every year the publication, a marketing exercise by the Cleveland Clinic, focuses on certain subspecialty areas within the discipline of the care and treatment of the musculoskeletal system. The obvious purpose of such a yearly event is to recruit referrals from practicing orthopedic surgeons and rheumatologists as well as the medical community in general.
This year the focus was on Adult Total Hip Arthroplasty for Osteoarthritis and Adult Unilateral Total Knee Arthroplasty for Osteoarthritis. I will summarize the results; let’s start with the hip:
“Hip-Related Pain 1 Year After Surgery: “on average, 92% of patients reported clinically important improvement in hip-related pain after 1 year, while 1% reported worsening (7% showed no detectable change in hip-related pain).”
“On average, 90% of patients reported a clinically important improvement in hip-related function after 1 year, while 1% reported worsening (9% showed no detectable change in hip-related function).”
The knee doesn’t fare as well:
“On average, 85% of patients reported a clinically important improvement in knee-related pain after 1 year, while 2% reported worsening (13% showed no detectable change in knee-related pain).”
“On average, 82% of patients reported a clinically important improvement in knee-related function after 1 year, while 2% reported worsening (16% showed no detectable change in knee-related function).”
The data was derived from patient self-reported scores collected during office visits up to 6 months before and 1 year after surgeries performed.
In my practice, every patient who undergoes a Bone Marrow Concentrate intervention is entered into an outcomes data base with both subjective and objective data points measured. It is quite comprehensive and numbers over 500 patients extending over a span now of 4 and ½ years. While the Cleveland Clinic report is based on subjective parameters and ours on both subjective and objective scores, I am able to extract subjective measures alone. I am pleased to report that in the case of the hip and the knee, our outcomes with a needle are equal to or better than those of the major surgery with a scalpel. Then factor in the prompt rehabilitation of a stem cell procedure compared with the prolonged rehabilitation inherent in a joint replacement. Lastly, consider the relative absence of complications of a stem cell intervention compared to the morbidity and mortality of a joint replacement.
Perhaps of greater significance to the stated advantage of a Bone Marrow Concentrate procedure for Osteoarthritis is the fact that no bridges are burned. If the patient is not satisfied at one year or five, a stem cell procedure may be repeated with a needle. If the arthritis progresses to an advanced stage, the fall back option is a joint replacement. The only choice following an unsatisfactory joint replacement is to accept the surgically induced impairment or undergo a risky revision surgery with a high likelihood of a complication or less than satisfactory outcome. Call 312 475 1893 to schedule an appointment today.
For more information watch my Regenerative Medicine Webinar Video
Tags: arthritis, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Interventional Orthopedics, joint replacement, knee replacement, Orthopedic Care, Orthopedics
Oct 15, 2016
Background: It is increasingly recognized that biochemical abnormalities of the joint precede radiographic abnormalities of post traumatic osteoarthritis (PTOA) by as much as decades. A growing body of evidence strongly suggests that the progression from anterior cruciate ligament (ACL) injury to PTOA is multifactorial, involving the interplay between biomechanical disturbances and biochemical homeostasis of articular cartilage.
Purpose: A randomized study using an acute ACL injury model were to (1) evaluate the natural progression of inflammatory and chondro-degenerative biomarkers, (2) evaluate the relationship between subjective reports of pain and inflammatory and chondro-degenerative biomarkers, and (3) determine if post injury knee drainage (arthrocentesis) and corticosteroid injection offer the ability to alter this biochemical cascade.
Study Design: Randomized controlled trial.
Methods: A total of 49 patients were randomized to 4 groups: group 1 (corticosteroid at 4 days after ACL injury, placebo injection of saline at 2 weeks), group 2 (placebo at 4 days after ACL injury, corticosteroid at 2 weeks), group 3 (corticosteroid at both time intervals), or a placebo group (saline injections at both time intervals). Patient-reported outcome measures and synovial biomarkers were collected at approximately 4 days, 11 days, and 5 weeks after injury. The change between the time points was assessed for all variables using statistical analysis, and the relationship between changes in outcome scores and biomarkers were assessed by calculating a commonly accepted mathematical analysis. Outcomes and biomarkers were also compared between the 4 groups using another statistical approach.
Results: No adverse events or infections were observed in any study patients. With the exception of matrix metalloproteinase 1 (MMP-1) and tumor necrosis factor–inducible gene 6 (TSG-6), chondro-degenerative markers worsened over the first 5 weeks while all patient-reported outcomes improved during this time, regardless of treatment group. Patient-reported outcomes did not differ between patients receiving corticosteroid injections and the placebo group. However, increases in C-telopeptide of type II collagen (CTX-II), associated with collagen type II breakdown, were significantly greater in the placebo group (1.32 ± 1.10 ng/mL) than in either of the groups that received the corticosteroid injection within the first several days after injury (group 1: 0.23 ± 0.27 ng/mL [P = .01]; group 3: 0.19 ± 0.34 ng/mL [P= .01]).
Conclusion: Post Traumatic Osteoarthritis begins at the time of injury and results early on in dramatic matrix changes in the knee. However, it is encouraging that early intervention with an anti-inflammatory agent was able to affect biomarkers of chondral degeneration. Should early intervention lead to meaningful changes in either the onset or severity of symptomatic PTOA, the current treatment paradigm for patients with ACL injury may have to be restructured to include early aspiration and intra-articular intervention.
This Blog is excerpted from a study appearing in the American Journal of Sports Medicine. My message, should you experience a significant joint injury, don’t wait until arthritic related symptoms appear, the Cellular Orthopedic intervention should take place within weeks; not years.
312-475-4523 to learn more or schedule an appointment
Tags: ACL Injury, ACL tear, arthritis, athletes, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, corticosteriod injection, Interventional Orthopedics, Knee, knee injury, Microfracture surgery, Orthopedic Care, Orthopedic Surgeon
Jun 30, 2016
Out is routine Medicare and insurance coverage indemnification of hyaluronic acid injections for osteoarthritic joints other than the knee. Additionally, several insurance carriers are now requiring pre-certification to determine if they will even cover hyaluronic acid injections of the knee. The phenomenon was first reported in Florida but now the reduction in coverage is spreading across the country including Illinois. A physician may decide to proceed with the single, thee part or at times five part injection series but it would be at the expense of the patient if insurance and Medicare deny coverage. The reason behind the decision has to do with long-term studies that fail to validate the claims of the many advertisements you may see on television or find in the newspaper concerning the various forms of hyaluronic acid as a gel.
Increasingly in is Amniotic Fluid Concentrate for Osteoarthritis even though not covered by Medicare or Insurance. The clinical trial regarding outcomes for said therapy are incomplete; and to the best of my knowledge, the only source of Amniotic Fluid Concentrate providers seriously investigating results is MiMedx, out of Marietta, Georgia. Nevertheless, there seems to be an ever-increasing presence of Amniotic Fluid Concentrate offerings in the medical marketplace; unfortunately with unsupported claims of a stem cell content. There does seem to be a benefit from amniotic fluid concentrate in relieving the symptoms of an osteoarthritic joint but we have to wait for completion of current clinical trials to understand proper dosage and the length of action.
If you are a regular reader of this Blog, you will have become familiar with the term Subchondroplasty, an adjunct that I have been offering on occasion in conjunction with Bone Marrow Concentrate/Stem cell procedures into the joint. The successes of Subchondroplasty are such that the attention to the bone supporting the joint when working inside the joint is a subject gaining increased attention on a national basis. It looks like the future will be an increasing combination of both intra-articular and extra-articular intervention. While no one is able to confirm why the decompression of the bone adjacent to a joint relieves pain and why the adjunct of biologics improves longer-term outcomes, attention to bone defects in the area around the joint is proving to make a major difference in outcomes for arthritis. The question now is whether the best approach is Bone Marrow Concentrate inside and outside the joint or Bone Marrow Concentrate inside the joint with a synthetic augment outside the joint?
Tags: Amniotic, arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx-SD, stem cells, Subchondroplasty, treatment
Jun 20, 2016
This past Thursday, I was reading the Steve Chapman article in the Chicago Tribune and in the article, he quoted French Sociologist Gustav Le Bon who is best known for his 1895 work The Crowd: A Study of the Popular Mind. While Chapman was trying to explain the Trump phenomenon, I saw an explanation as to why patients with arthritis make decisions as to how to proceed with care. At the recent Orthopedic and Biological Institute meeting in Las Vegas, speaker after speaker including napropaths, chiropractors, and non-board certified physicians presented a show and tell as to how they approach arthritis in this day of expanded access to orthobiologics. The explanations given approached the realm of fantasy; missing from the several day event were science, outcomes and results.
In the past several months, I have watched the entry of large orthopedic companies, with whom I have had a 40-year plus joint reconstruction relationships, into the growing specialty of Orthobiologics. These companies not only bring research support into our specialty of cellular (interventional) orthopedics, they carefully scrutinize those with whom they partner so the net result is evidence based patient care, research and education; not unfounded claims by “Camp Followers”. Witness the ad in a suburban newspaper placed by chiropractors offering stem cell containing amniotic fluid for the treatment of arthritis. I have written about this scientifically unfounded claim in this Blog before and I will emphasize it again, there are no living stem cells in amniotic fluid after processing, irradiating and fast thawing.
Assume if you would that you have an arthritic joint wherein your symptoms and limitations are no longer responsive to cortisone injections, anti-inflammatory medications, physical therapy, hyaluronic acid injections and the like. Your choices historically have been to either wait until end stage arthritis and then have a joint replacement or have a joint replacement early on and risk the potential adverse life changing consequences versus the potential benefits. Today there is an alternative option that will help postpone a joint replacement or possible help avoid one; it falls within the emerging discipline of Regenerative Medicine. Warning though, don’t be a victim of illusion; seek out a consultation and opinion from a board certified specialist who integrates cellular orthopedic patient care with research and education.
Call (312) 475-1893 to schedule your Orthobiologic consultation.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, joint replacement, Knee Pain Relief, Orthopedic Care, Orthopedic Surgeon, Osteoarthritis, Regenerative, stem cells, technology, treatment
Sep 17, 2015
In the last week, I have become aware of four companies developing new regenerative medicine product for Musculoskeletal Care of the Aging Athlete. What I find extremely interesting is the fact that three years ago, when I entered the practice of using bone marrow aspirate concentrate in an attempt to postpone or possibly avoid a joint replacement in an arthritic knee or hip, the orthopedic community was very critical telling patients that regenerative medicine was still ten years away. Fast forward three years and four new initiatives into the emerging field of regenerative medicine have come to my attention; underwritten by orthopedic surgeons or companies that have produced prosthetic joints for over 30 years. All of the product in development has not yet been approved by the FDA and many developing products are still being tested in Europe. What we at the Regenerative Pain Center offer is within FDA guidelines and approved by all regulatory agencies of the government. At the same time, I am very much aware of what is taking place nationally and internationally; when a newer regenerative medicine product is made available and FDA approved, we at the Regenerative Pain Center will be aware and closely evaluate as to whether it should be incorporated into our service line.
Let me be candid, our success rate is not 100 per cent. There have been three or four hip patients that have not provided the outcome the patient sought or that I hoped to provide; namely, avoidance of a hip replacement. On the other hand, the vast majority of hip bone marrow aspirate concentrate procedures are still allowing the patient a very full return to activities with about 70% percent patient satisfaction at a minimum of one year. When it comes to those who sought help for an arthritic knee, we have done even better with an 85% patient satisfaction outcome at a minimum of one year. Several of those patients had reached a plateau at six months but realized a marked improvement in the pain score with a Platelet Rich Plasma refresher. When a patient elects to under go a bone marrow aspirate concentrate hip or knee intervention at the Regenerative Pain Center, that patient may be assured that what we are doing is based on FDA guidelines and our clinical outcomes research. In addition, each patient should recognize that Regenexx continually statistically reviews our outcomes data. Last week, we recognized that those who underwent Cellular Orthopedic interventions for an arthritic knee did best when the cell count of mononuclear cells exceeded 400 million. Be aware that we count the cells in every Regenerative Medicine procedure. Our approach is no longer “this is the way we do it.” Our approach is based on experience and outcomes research, the same that I used in a long joint replacement career.
Tags: arthritis, athletes, Benefits and Risk, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, FDA, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, Orthopedic Care, Orthopedics, Osteoarthritis, Pain Management, Platelet Rich Plasma, Regenerative, Regenerative Pain Center, Regenexx, stem cells, treatment
Apr 2, 2015
Intervertebral disc degeneration is characterized by a gradual loss of cellular function and related breakdown of extracellular matrix. This process leads to a decrease in the mechanical stability of the spine and activation of molecules that trigger painful back and neck symptoms. Implantation of mesenchymal stem cells has been shown to counteract the degenerative process in animal models of disc degeneration and in some initial clinical studies. The regenerative activity of Mesenchymal Stem Cells when injected into the disc results in a reversal of that degenerative disc process. In addition, the injection of MSCs also releases trophic factors that may stimulate the metabolism of disc cells and suppress inflammatory reactions. However, in spite of these promising perspectives, clinical application of MSCs has certain limitations. Potential adverse events such as cell leaking and osteophyte (spur) formation are at present, the limiting factors. I am updating my Blog readers concerning what is on the horizon as every week I receive a question about the subject of the low back and stem cells. Low Back degenerative disease also is something I must consider in each and every patient for whom I perform a Cellular Orthopedic intervention in a hip or knee as there is no question about a Hip-Knee-Spine connection and I must understand its importance when I treat hip and knee pathology. These areas are closely related in function and symptom distribution
The limitation at present of Cellular Orthopedic intervention for intervertebral disc degeneration is the need to further identify potential side effects. While an attractive target for future regenerative strategies, Bone Marrow Aspirate Concentrate/Stem Cell intervention is not ready for prime time. The logical question then is how to cope with the limitations of spinal stenosis and Degenerative Disc and Joint disease of the low back until stem cell care is proven safe and effective? First and foremost comes weight reduction. Next in line is core strengthening in conjunction with stretching. This may be accomplished through Pilates, Tai Chi, Yoga and any other program that follows the principles of strengthening and stretching the core. Incidentally, running and jogging are not injurious to an arthritic spine; just the opposite, both help rehydrate the dried out disc.
To learn more about your personal kinematic Knee-Hip-Low Back continuum, you need an assessment. That’s the only way I can determine the key problem and if one or all need to be addressed.
847 390 7666 to make an appointment
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Interventional Orthopedics, Mature Athlete, medicine, Regenerative, Regenexx, stem cells, treatment
