Until 2002, the patient seeking a joint replacement consultation would ask me “how long will new joint last”? Then came the era of minimally invasive surgery -I played a major role in the introduction-and now the question became “how long is the incision?” and “how long will I stay in the hospital?” While the number of “Regenerative Medicine” options for the treatment of osteoarthritis continues to increase, in the current medical marketplace, it is via direct to consumer advertising that “breakthroughs” are brought to the attention of those impacted by the symptoms and limitations of Degenerative Joint Disease. Whereas patients historically would base their personal medial decision making on consultation and guidance from the medical community, such is no longer the case. Media marketing is now the primary reason a patient makes the decision for which Regenerative option to choose. The problem is there is little if any scientific evidence to support the ad claims. In the one or two approaches where there is a paucity of evidence, the latter is on a handful of subjects at less than six months. Witness the recent reversal on insurance reimbursement for several placental derived products because of the absence of benefit at six months in clinical trials.
Included among the reasons featured in ads promoting Stem cells for arthritis, you will find,” it worked for me”. More recently it is a product that “recruits” your Stem Cells. On it goes with promotions for Stem Cells in cord blood, Stem Cells in Wharton’s Jelly, and Stem cells derived from your adipose tissue (fat). Missing from the entire marketing campaign in almost every scenario is outcomes data. I am an orthopedic surgeon who, prior to my Cellular Orthopedic initiative, played a major role in joint replacement surgery as Professor of Orthopedics and head of a prominent joint replacement program at a large Medical Center in Chicago. While performing clinical trials with new generations of hip and knee implants, it was well accepted in the orthopedic community that a minimum of two year follow up would be required before a scientific paper would be considered for publication. When I entered the emerging specialty of Cellular Orthopedics, I continued the integration of clinical practice with clinical research so that my interventional recommendations would be evidence based. Below are two of the manuscripts I co-authored; one having been accepted for publication and the other recently submitted for publication.
Safety and Efficacy of Percutaneous Injection of Lipogems Micro fragmented Adipose Tissue for Severe Osteoarthritic Knees
A Specific Protocol of Autologous Bone Marrow Concentrate and Platelet Products Versus Exercise Therapy for Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial with 2 Year Follow-Up
What I won’t promote is anything wherein there is not two years minimum of evidence concerning safety, efficacy and satisfactory clinical outcomes. I am not opposed to progress but best practices demand clinical trials of new options and those trials should be underwritten by the pharmaceutical company; not by a patient paying relatively large sums without meeting inclusion criteria and without follow-up leading to minimum two-year outcomes evidence.
To learn more, schedule an appointment (312) 475-1893. You may visit my website www.Sheinkopmd.com
Tags: adipose tissue, Bone Marrow Concentrate, cellular orthopedic, lipogems, OA, PRP, stem cells