Henry T. Leis, M.D. of Bienville Orthopaedic Specialists, Biloxi, Mississippi, performed the first-in-man surgery of an implant that can be used in the wrist or hand. He said, “We are proud to be the first center to implant the Ensemble CMC. This technology provides a promising alternative to the more invasive procedures that are available to treat osteoarthritis of the CMC (carpometacarpal). We are excited to be able to offer our patients this new solution.”
First-In-Man for Novel Carpometacarpal Treatment
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#osteoarthritisSecondary#interpositionalimplant
The surgery occurred at Memorial Hospital-Gulf South Surgery Center in Gulfport, Mississippi on March 23, 2021.
The new minimally invasive implant, brand named Ensemble CMC, was developed and is manufactured by Ensemble Orthopedics, Inc.
Ensemble CMC is FDA-cleared for sale in the United States and was designed to provide more treatment options for patients with osteoarthritis of the carpometacarpal. The company and its medical advisors designed both the implant and its instrumentation so that the procedure can be performed minimally invasively and can, potentially, deliver a shorter recovery time to the patient.
The Ensemble CMC implant incorporates a proprietary saddle shape which replaces the bearing surfaces of the metacarpal and trapezium bones that have been damaged by osteoarthritis.
The implant is fabricated with On-X pyrocarbon, a biocompatible material that is strong, durable and highly resistant to wear and tear—particularly as compared to metal or ceramic implant materials.
“Osteoarthritis of the hand is a debilitating disease that affects 40% of U.S. adults by age 85,” said William Ogilvie, Ensemble Orthopedics president and chief executive officer.
“Our innovative treatment approach inserts an implant through a small incision while retaining the surrounding soft tissues that stabilize the joint. Ensemble is dedicated to bringing this stemless, interpositional philosophy to the other joints of the hand and wrist.”
He, added, “The collaboration between our team and Dr. Leis to achieve the first implantation of the Ensemble CMC™ was enjoyable and productive. We will continue to train select surgeons on the Ensemble procedure, enabling us to complete our controlled commercial launch.”
Ensemble Orthopedics, based in Austin, Texas, is a medical device company that focuses on minimally invasive surgical techniques for the treatment of arthritis of the hand and wrist.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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