Study of Spongioflex Allograft for Partial Meniscus Replacement in Adults With Partial Meniscal Loss

What this Trial Is About

This research aims to learn if partial meniscal replacement can improve knee function and delay or avoid the need for total meniscal replacement or knee prosthesis in adults with partial meniscal loss. The study compares patients who receive surgery with those who do not undergo surgery to see if the operation leads to better outcomes over time. Participants in the operated group will receive an arthroscopic surgery implanting a demineralized bone block called Spongioflexae into the meniscus defect, secured with sutures. This biological implant is designed to support cell growth and restore meniscus function. The surgery lasts 60-90 minutes, with a hospital stay of 2-3 days. Follow-up visits occur at the end of the hospital stay, 6 weeks, and then at 6, 12, 24 months, and 5 years after surgery. The non-operated group does not receive surgery but has follow-up visits at 6, 12, 24 months, and 5 years. During the study, participants will undergo MRI scans and complete knee function and pain questionnaires at follow-up visits. Researchers will measure improvements in knee scores such as the International Knee Documentation Committee IKDC score, Knee Injury and Osteoarthritis Outcome Score KOOS, and Visual Analogue Scale VAS for pain. Safety will be monitored by tracking adverse events, and other outcomes include meniscus size, extrusion, patient satisfaction, and progression to osteoarthritis. The total participation spans up to 5 years.

Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss