Partial Meniscal Replacement Using Spongioflex Allograft An Investigator-Initiated Trial After Incomplete Meniscal Loss Evaluating Knee Function and Pain Outcomes

What this Trial Is About

Researchers are studying a new biological implant called Spongioflexae for partial meniscal replacement in patients with partial meniscal loss and related knee pain. The study aims to see if this novel graft can avoid or reduce problems seen with previous materials and improve patient outcomes compared to those who do not have surgery. Since there is currently no biological alternative available, this study is medically and economically important. The meniscus plays a key role in knee stability and pressure distribution, and partial meniscus loss can lead to arthritis and the need for knee replacement surgery over time. During the study, patients undergoing surgery will receive an antibiotic shot before the procedure. The Spongioflexae implant, made from demineralized human bone, will be arthroscopically placed into the meniscus defect and secured with sutures. The implant is flexible, porous, and designed to support cell ingrowth and tissue regeneration. Surgery lasts about 60-90 minutes, with a hospital stay of 2-3 days. Follow-up visits are scheduled at hospital discharge, 6 weeks, 6 months, 12 months, 24 months, and 5 years after surgery. Participants will be evaluated using several knee function and pain scores at these time points to assess the implant's effectiveness. The study also includes MRI imaging to monitor meniscus incorporation and joint health. Researchers will track safety, function, and long-term outcomes related to pain, knee function, and arthritis progression. The total follow-up period extends to 5 years, providing data on both short- and long-term effects of the implant.

Partial Meniscal Replacement with Spongioflex®