Sterile Allogeneic Spongioflexae Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss, An Investigator-Initiated Trial

What this Trial Is About

This research investigates the use of a novel biological graft, Spongioflexae, for partial meniscal replacement in patients with symptomatic, degenerative, and irreparable damage to the medial or lateral meniscus. The study aims to assess whether this new implant can avoid or delay the disadvantages associated with previous replacement materials and reduce the need for total knee arthroplasty (TKA). Since no current alternative biological material exists, this trial holds significant medical and economic importance. Previous research shows that successful meniscal repair improves clinical knee function and MRI imaging outcomes. Participants who choose surgery will receive the Spongioflexae implant during an arthroscopic procedure, where a demineralized allogenic bone block is fitted to the meniscal defect and secured with sutures. Surgery lasts 60 to 90 minutes with a hospital stay of 2 to 3 days. Patients who opt not to have surgery will be closely monitored and may join the operated group later. Follow-up visits occur at hospital discharge, 6 weeks, 6, 12, 24 months, and 5 years after implantation. Throughout the study, participants undergo evaluations including MRI scans to assess meniscal size, extrusion, and cartilage condition, as well as clinical knee scores like KOOS, IKDC, and VAS pain measured at multiple time points. Safety is monitored by recording adverse events. Patient satisfaction questionnaires are also completed. The research team tracks the procedure's effectiveness in preventing or delaying the progression to knee replacement, with total participation lasting up to 5 years.

Partial Meniscal Replacement with Spongioflex®