PROCESSED MENISCUS ALLOGRAFT: PRELIMINARY RESULTS OF PHASE II STUDY

Background The objective was to evaluate the benefit that could be obtained in terms of pain and efficacy with processed segmental allografts on 20 patients in meniscal repair treatment. Methods Segmental meniscal allografts were extracted from tibial plateaux during total knee arthroplasties on lateralised osteoarthritis and selected on macroscopic integrity criteria. They underwent decellularisation and deproteinisation processes to obtain a sterile collagenous matrix with glycosaminoglycans removal. Under arthroscopy, the grafts (50mm length) were fixed at the posterior horn and at the meniscosynovial wall. The main evaluation criterion was the IKDC subjective knee score evolution. Secondary criteria were the meniscus morphology (Magnetic Resonance Imaging after 12 months) and the recellularisation (biopsy after 1 year). Material In this Phase II monocentric, prospective and open-label clinical trial, a total of 10 male patients (mean age: 39 years [24–50]) were enrolled. They were symptomatic (IKDC score < 70), did not suffer from osteoarthritis (Kellgreen-Lawrence score < Grade 2) and presented a meniscal tissue defect on the posterior and/or medium segment, respecting the posterior horn. Exclusion criteria were lax knees, significant frontal deviations, pre-osteoarthritis and obese patients. Results One patient dropped out. The mean IKDC score increased from 45 points [23 to 70] at the inclusion to 70 points [49 to 90] after 1 year. The MRI and biopsies results are currently being analysed. The first biopsies studied show that the allograft is cellularised with fibroblasts and chondrocytes. Conclusions The functional results are encouraging, at least equivalent to the ones obtained for massive grafts. Indications for segmental allografts are difficult to prescribe early and the surgical technique is challenging; these two facts contribute to good outcome. The early clinical results are positive, while awaiting the morphological and histological outcomes in a few months. Level of evidence III