The U.S. Food and Drug Administration (FDA) has provided 510(k) clearance to a device for reconstructing torn knee ligaments in children and adolescents.
FDA Clears Device for ACL Reconstruction in Children
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Secondary#arthrex#acltightrope#pcltightrope#tightropesystem
According to the 510(k) summary, the devices are “intended to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.” The company will be offering the devices for “ACL/PCL [anterior cruciate ligament/posterior cruciate ligament] repair and reconstruction for the adult and pediatric patient population.”
Arthrex Inc., a medical device company based in Naples, Florida, submitted the application. For the past 15 years, Frank A. Cordasco, M.D., MS, a sports medicine surgeon at Hospital for Special Surgery (HSS), and Daniel W. Green, M.D., MS, FAAP, FACS, a pediatric orthopedic surgeon at HSS, have been working together in collaboration with Arthrex to aid in the evaluation of the clinical effectiveness of the device.
The devices include the Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices. In the press release, Dr. Green explained, “The ideal patient for the procedure is, in general, a child between the ages of 12 and 15 to 16, depending upon the athlete’s skeletal maturity, at which point the growth plates are effectively closed.”
The technology builds off of an existing device used in adults undergoing ACL reconstruction. However, this device, has “features specifically designed to accommodate the growing skeletons of young athletes.” This new technique offers the advantage of allowing surgeons “to tension the graft sequentially to ensure proper fixation and strength and to utilize minimally invasive techniques to diminish damage to the growth plates while performing a successful reconstruction.”
Dr. Cordasco explained, “Surgery to utilize the implant for graft fixation is more efficient and effective than previous methods and has been shown to result in more successful outcomes.”
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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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