On October 28, 2013, I received IRB approval for a clinical trial with Regenexx Sciences, LLC as the sponsor and me as the Principal Investigator. The study, A Randomized Controlled Trial of Regenexx SD versus Exercise Therapy for Treatment of Knee Osteoarthritis with Historical Comparison to Total Knee Arthroplasty, was undertaken by me because of my recent “graduation” from joint replacement surgery to the new world of interventional orthopedics and because of my 37-year history as a joint replacement pioneer. Earlier this month, I was able to begin forwarding outcomes data to Regenexx in Broomfield, Colorado, for statistical tabulation. The results of this trial will not only impact what and how the Regenexx Network will make interventional recommendations, as the first and most comprehensive study of its kind, it will serve as the basis for comparison of all ongoing and future Regenerative Medicine methodologies for the care and treatment of the arthritic knee.
From Stem cells to Growth factors, the integration of our clinical research and clinical practice is having a major impact within the field of interventional orthopedics. Our results are allowing patients to return to activities they enjoy using a needle instead of a knife. I do not claim to be a cellular biologist but my network now allows me insight into the latest cellular advances. With the incorporation of the Abbott’s Ruby cell counting system into my clinical practice, I now customize the Bone Marrow Concentrate to the individual needs of a patient and thus not only quantitate but qualitate that which I inject into an arthritic joint.
Many Musculoskeletal injuries and certainly arthritis, do not heal with conservative management and historically required surgical intervention. The most contemporary method of effecting healing and regeneration is both Platelet Rich Plasma and Bone Marrow Concentrate. If you take a second look at the title of the clinical trial cited above, you will see the complete title ends with “Historical Comparison to Total Knee Arthroplasty”. The control group for the trial were patients with an arthritic knee in whom I had performed Total Knee Replacements during my surgical years. I am one of the few Orthopedic Surgeons who have experiences both in joint replacement surgery and interventional orthopedics. The majority of stem cell recipients have returned to activities they enjoy; the majority of Total Knee recipients are couch potatoes. When the numbers become available after statistical tabulation, I will post the data on my Blog.
Recently, I became aware of a relatively new web site www.Desirelist.com. The web site allows you to discover, capture and list all you may desire with a high probability of realizing your desires. So, I went on line and listed that which I want for my patients in 2017; namely, Internal Peace in a World at Peace. Where I can make a difference for those limited by arthritis of a major joint , and deliver on your desire for an improved quality of life is through Regenerative Medicine and Interventional Orthopedics.
Happy Chanukah, Merry Christmas and Happy and Healthy New Year
Tags: ACL Injury, arthritis, athletes, bone marrow, Clinical Trial. Mitchell B. Sheinkop, Growth Factors, Hip Replacement, Orthopedic Care, stem cells, treatment
I am receiving increased requests for my Outcomes Data following a Bone Marrow Concentrate intervention for osteoarthritis of the hip. There is a paucity of said outcomes data in the scientific literature in part because of the relatively recent introduction of Regenerative Medicine for Osteoarthritis. I believe equally important is the fact that I was one of the first orthopedic surgeons to embrace the practice and remain one of the few in the subspecialty who practices evidence based medicine through the integration of clinical research with a clinical practice. Perhaps the recent presidential campaign, where honesty took a beating across the US, is responsible for the heightened patient awareness of the charlatans victimizing the public when it comes to Regenerative Medicine.
There is no question that there is value in facts and that is why my cellular orthopedic initiative is evidence based. Earlier this week, owing to these patient inquiries about my particular data base results when it comes to stem cells and growth factor for the hip, I reviewed my data base. There are now just over 150 patients with osteoarthritis of the hip who have undergone a Bone Marrow Concentrate intervention of the hip. The introduction of those bone marrow derived Mesenchymal Stem Cells and Growth factors has the potential to relieve pain, improve function, increase motion, regenerate the cartilage, alter the natural history of the arthritic joint, and delay, perhaps help avoid a hip replacement.
In order to qualify for submission to an orthopedic journal or scientific meeting, orthopedic data must be statistically significant with greater than a two-year follow-up. Our numbers will reach those criteria by January 1, so I thought I would present the preliminary data in this Blog format.
Of the 150 arthritic hips with grade 2 and 3 osteoarthritis at the time of the intervention over the past four years, 92% of patents on average, reported a clinically important improvement in hip-related pain after 1 year while 1% reported worsening. To the best of my knowledge, one patient in the group progressed to grade 4 osteoarthritis and elected to undergo a Total Hip Replacement. As far as Hip-Related function after a minimum of 1 year, 90% of patients reported a clinically significant improvement while 1% reported worsening. Of importance is the fact that of the 9% who initially showed no detectable change in hip-related function, all 9 were significantly improved by a booster intervention.
During my four and one half year, Interventional Orthopedic practice, I have learned that when a patient doesn’t reach a sought-after goal while under observation, a repeat intervention be it Platelet Rich Plasma or a Bone Marrow Concentrate, is a very important part of achieving success. Herein is the basis for my integration of a clinical research initiative with timely follow-up as contrasted with a procedure, a bill and a goodbye. If you want to learn more about evidence based Cellular Orthopedics be it for an arthritic hip or knee, call and schedule a consultation.
312 475 1893
Tags: arthritis, Bone Marrow Concentrate, Clinical Studies, Clinical Trial. Mitchell B. Sheinkop, Hip Arthritis, Hip pain, Hip Replacement, hip surgery, Interventional Orthopedics, Orthopedic Care, Osteoarthritis
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
Aging is known to contribute to a multitude of systemic changes including those of the musculoskeletal system leading to decreased health, mobility and function. Most changes in well-being are exacerbated by inactivity. It has been scientifically documented that physical activity and exercise may slow or even reverse these deleterious effects thereby improving health, mobility and function.
In particular, ligaments, tendons and joint capsules become stiffer with age as elastic fibers decrease and cross-links between collagen fibers increase. As connective tissue surrounding the joint changes, so too does the synovial fluid within the joint making movement more difficult. Not only do changes occur within the joint, they also occur in the muscles. The loss of muscle mass and strength also known as sarcopenia, increases with age. Then there is the fatty infiltration of muscle that comes with aging and lack of use.
Recognizing the value of Bone Marrow Concentrate derived Stem Cells, Cytokines and Growth Factors in dealing with his arthritic hip when the alternative was a joint replacement, seven months ago, a 58-year-old man underwent a cellular orthopedic intervention. Over the past many months, the patient committed himself to a minimum of 30 minutes a day, five days a week at moderate intensity aerobic exercise alternating with three days a week at vigorous intensity. In addition, he partook in resistance exercise a minimum of two days a week at a moderate high intensity focusing on 10 exercises at each session targeting most major muscle groups, with 10 to 15 repetitions for each exercise performed thus adding an additional 20 to 30 minutes to the commitment. Then there are the benefits of his additional flexibility and stretching. When this individual came to me at his first visit, his stated goals were to return to a high level of recreational enjoyment with a particular interest in ball room dancing. As of last week, he had reached those goals but he has no intention of failing to comply with his exercise prescription.
The obvious message of my Blog is to let you know I am unable to reach a desired goal without your commitment. I may introduce Stem Cells, Cytokines and Growth Factors into an arthritic joint but to reach your desired goal or delay or perhaps avoid a joint replacement, those many changes that occur with aging can be slowed and even reversed by a combination of cellular orthopedics and exercise.
If you want to learn about the evidence, schedule an appointment 312 475 1893
Tags: arthritis, athletes, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Concentrated Stem Cell Plasma, Growth Factors, Hip, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, Mature Athlete, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, regenerative medicine, Regenexx, stem cells, treatment
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