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
The FDA again held a meeting to address issues pertaining to Regenerative Medicine. At the conclusion of the meeting, an updated set of guidelines was developed for patient protection in the use of stem cells, growth factors, and platelet rich plasma. While still being interpreted by the Regenerative Medicine community, what becomes clear is the call for better self-regulation. It is not ethical or acceptable for anyone holding themselves out to be practicing cellular medicine to hold a seminar, recruit a patient, inject some substance into a joint and request payment. Equally important are the credentials of that practitioner.
For the past four and a half years, I have followed the outcomes of all my patients using the same subjective and objective parameters in my practice of Interventional Orthopedics that I used to follow the results during my joint replacement career. Over that 37-year span, because of my data collection initiative, many new generations of Hip and Knee Prostheses were introduced into adult reconstructive orthopedic surgery. Statistical analysis of data allows for progress in care and development of new product. Today, I still gather outcomes data for each patient. That initiative has led to refinement and advances in the emerging subspecialty of Regenerative Medicine; both in my own practice and around the globe.
Anticipating the future, I am headed off this upcoming weekend to join a small group of those looking to the future in advancing the practice of cellular medicine. Up until now, our data collection and Outcomes registry was clinical in nature; in a short time, that data will also include cellular data. This latter is the next way to refine the practice of regenerative medicine.
By having tighter control over the composition of autologous PRP and BMC preparations for use in my practice of regenerative medicine, through comprehensive analysis of autologous patient samples, I will have a chance to see what levels of important constituents like Stem Cells, Growth Factors, Platelets, RBCs, WBCs, and so on are present in the preparation.
How might I take advantage of the data? The most obvious use would be for me to record values of your sample analysis in a spreadsheet and enter in demographic and clinical outcomes data. I will continue to enter your results of outcomes assessments obtained during follow-up visits that I routinely use to monitor your recovery. By applying this strategy to all patients I treat, an internal database will inform me about optimization strategies for treating my patients, allowing me to modify and customize the make-up of that which will be injected. Why go to the trouble, you might be asking yourself? Having a detailed knowledge of what I am injecting into my patient puts me in a position to refine my practice of regenerative medicine. And that is a good thing, since you the patient ultimately will benefit from my optimizing the use of autologous materials like PRP and BMC.
To schedule your appointment call 312 475 1893
Tags: arthritis, BMC, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Growth Factors, Hip Replacement, Interventional Orthopedics, joint replacement, Knee Pain Relief, knee replacement, Osteoarthritis, Pain Management, Platelet Rich Plasma, platelets, PRP, regenerative medicine, stem cells, Ultrasound Guided Injection
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
Introduction and background
While the benefits of total hip replacements are numerous, there is a known incidence of associated pain leading to early revision. Have attempts at improving the prosthetic implant, shortened lengths of hospital stay, minimally invasive procedures and metal on metal bearings been a process of revolution or as in the case of Gulliver, devolution?
The goal of the surgeon has historically been pain relief and a 20-year plus satisfactory outcome when performing a total hip. More recently, survivorship prioritization seems to have been replaced by restoration of hip anatomical geometry, thereby optimizing muscle tension and strength, equalization of leg lengths, and enhancement of hip stability all via modularity. The newer generations of prostheses have been designed in an attempt to facilitate and accommodate the latest fads in surgical approaches so as to lessen the scar length, perhaps minimize muscle damage-still a matter of debate-and return the patient to full activity status in days or weeks rather than months.
I just received an AMA alert that by 2030, 42% of Americans will be obese. Short incision, less hospital stay, prompt return to activity, who are we kidding? Lets look more closely at the cost of supposed progress in the newest prosthetic designs.
Metal Fretting and Corrosion. This has been reported with cobalt chrome and cobalt chrome- titanium junctions. The more modularity and junctions between metals, the more potential metal debris generation. Metal on metal bearings produce small metallic wear debris. Furthermore, elevated blood serum ion levels and metal hypersensitivity resulting in an adverse local tissue reaction may occur with metal-metal articulate surface bearings causing premature failure due to osteolysis, aseptic loosening and pseudo tumor formation.
So what should you do and look for whether or not you are in pain after a total hip replacement?
Evaluation for infection-a screening serum ESR, C-Reactive Protein, and WBC. If any of these are abnormal, a hip aspiration need be performed.
Serum metal ion levels-serum chromium ion levels above 17ug/L and cobalt ion levels above 19ug/L suggest metallosis within the joint. Pseudotumors have been found at lower levels and are identified by ultrasound and CT scans. In the United Kingdom, the cut off level is 7 parts per billion (7ppb) chromium or cobalt.
Metal hypersensitivity-Nickel is the worst offender but chromium and cobalt may play a role. The problem is the area is still poorly understood with the only available testing including patch testing and the lymphocyte transformation test.
Radiographic analysis-Your physician will look for signs of loosening, osteolysis and pseudotumor formation
If you have a painful total hip replacement, you need an evaluation.
There is another consideration, postpone or avoid the replacement. Might Regenerative medicine and stem cell management, help control you pain and possibly postpone or even help avoid a total joint replacement?
Mitchell B. Sheinkop, M.D.
312-475-1893 or 312-475-1893
1565 N. LaSalle Street
Chicago, Illinois 60610
Tags: Hip Replacement, Osteoarthritis, Regenerative Pain Center, stem cells
British Hip Society recommends against use of stemmed, large diameter, metal-on-metal implants in primary total hip replacements.
Based on discussions held at its annual meeting, the British Hip Society (BHS) has issued a statement on the use of large diameter metal-on-metal bearing total hip replacements. BHS advises that stemmed, large diameter metal-on-metal primary total hip replacements using bearings of 36 mm or greater should no longer be performed until more evidence is available, except in properly conducted and ethically approved research studies. The advice does not apply to hip resurfacing. In addition, BHS endorsed guidance recently issued by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), calling for annual monitoring for the life of the implant, as a precautionary measure.
FDA committee to discuss reports of joint destruction associated with anti-NGF drugs.
The U.S. Food and Drug Administration (FDA) plans to hold a meeting next week to discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development, along with safety issues possibly related to the drugs. Anti-NGF drugs are being developed for the treatment of chronic painful conditions such as osteoarthritis, chronic lower back pain, cancer pain, and other conditions. An advisory committee will be asked to determine whether reports of joint destruction represent a safety signal related to the anti-NGF class of drugs, and whether the risk-benefit balance for these drugs favors their continued development as analgesics.
Sheinkop meets with Regenexx in Colorado to evaluate new office based needle arthroscopic system
While it is true that I was skiing last week in Vail, while I vacationed, I still worked on assuming a leadership position in the new world of regenerative medicine. What I as an individual am able to contribute is my background and experience in research and clinical practice of treating arthritis with joint replacement surgery. Now I am dedicating myself as an orthopedic surgeon to avoiding or postponing joint replacement. When arthritis is debilitating and the X-ray is that of bone on bone, there is still an indication for a new hip or a new knee. But patient beware, there are restrictions inherent in a new joint. My life-long biking, skiing and fly fishing buddy, has relatively severe arthritis of his left knee. Yet he still can bike faster and ski better than me-I out fish him-because he has taken my counsel and postponed, maybe avoid a knee replacement via Regenerative Medicine.
To learn if you are a candidate for regenerative medicine, feel free to call
Mitchell B. Sheinkop, M.D.
312-475-1893 or 312-475-1893
1565 N. LaSalle St, Chicago, IL 60610
Tags: bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, FDA, Osteoarthritis, Pilot Study, Regenerative, Regenerative Pain Center, Regenexx, stem cells
(From the American Academy of Orthopedic Surgeons Patient Information initiative)
On May 6, 2011, the Food and Drug Administration (FDA) issued a postmarket surveillance studies of total metal-on-metal hip replacement devices. A postmarket surveillance study monitors adverse events after a device has been approved or cleared by the FDA
Although the vast majority of patients have not had any problems with MoM implants, orthopaedic surgeons and the FDA are concerned because a few cases reported in the peer-reviewed literature and through a British database have involved patients who had local hip symptoms (pain and swelling) as well as other medical concerns seemingly unrelated to the hip.
The following is the patient-education portion of the FDA’s patient health communication:
How often should I follow-up with my orthopaedic surgeon?
If you develop new or significantly worsening symptoms or problems with your hip, including pain, swelling, numbness and/or a change in ability to walk, contact your orthopaedic surgeon right away.
What symptoms might a metal-on-metal hip implant cause?
Symptoms may include hip/groin pain, local swelling, numbness or changes in your ability to walk. There are many reasons a patient with a metal-on-metal hip implant may experience such symptoms and it is important that you contact your surgeon to help determine why you are having them.
Are there other medical effects that can occur with my metal-on-metal hip implant system?
Metal-on-metal hip implants, like other types of hip implants, are known to have adverse events, including infection and joint dislocation. There are some case reports of the metal particles causing a reaction around the joint, leading to deterioration of the tissue around the joint, loosening of the implant, and failure of the device, as well as some of the symptoms described above. In addition, some metal ions from the implant may enter into the blood stream. There have been a few recent case reports of patients with metal-on-metal hip implants developing a reaction to these ions and experiencing medical problems that might have been related to their implants, including effects on the nervous system, heart, and thyroid gland.
What should I do if I am experiencing adverse events associated with my metal-on-metal hip implant?
1. If you are experiencing hip/groin pain, difficulty walking or a worsening of your previous symptoms, you should make an appointment to see your orthopaedic surgeon for further evaluation of your implant. Your orthopaedic surgeon may wish to perform a physical exam and an evaluation based on your symptoms.
2. If you experience any new symptoms or medical conditions in your body other than at your hip, you should report these to your primary physician and remind them that you have a metal-on-metal hip implant system during their evaluation.
What does it mean when I see that a hip implant system has been “recalled?”
A hip system may be recalled by the manufacturer for a number of reasons. If your device is recalled, this does not necessarily mean that the device needs to be removed and replaced. In some cases, the recall just calls for different or more frequent monitoring. It is important to discuss the reason for the recall with your surgeon to determine the most appropriate course of action. If you are unsure if your hip implant was recalled, consult with your orthopaedic surgeon. Additional information on the recall can be obtained from the manufacturer or from: FDA Medical Device Recall InformationFDA Medical Device Recall Information
With the risk of adverse reactions to metal-on-metal hip implant systems, why are these devices still being offered to patients?
It is known that every different type of hip implant system has its own set of risks as well as its own set of benefits. FDA’s assessment of medical devices such as metal-on-metal (MoM) hip implants is based on a risk-benefit ratio with the data available. MoM hip implants overall have been shown to provide significant benefits (e.g., high survivorship) in certain patient populations. Although the exact prevalence of adverse reactions to metal-debris is not known, current experience leads us to consider the adverse outcomes to be relatively low or equal to other types of hip implants. Thus, for many patients, currently available information supports a favorable risk-benefit ratio.