SHORT TERM CLINICAL OUTCOME AFTER IMPLANTATION A NOVEL MENISCUS SCAFFOLD IN PATIENTS WITH MENISCAL TEAR OR MENISCAL LOSS

Abstract

Introduction: Currently, partial meniscectomy represents the only viable treatment option for patients with irreparable meniscal tears; however, functional limitations have been reported both in the short- and long-term. Furthermore, over time, removal of knee meniscus tissue leads to degenerative joint changes and osteoarthritis. Given the limited alternatives to meniscus removal, researchers have developed a novel meniscal scaffold. Upon implantation to the vascularized portion of the meniscus, the scaffold allows the ingrowth of blood vessels, facilitating the regeneration of meniscal tissue.

Methods: A total of 52 patients with an irreparable medial or lateral meniscal tear or partial meniscus loss (with intact rim) were recruited into this prospective, non-randomised, single-arm, multi-centre clinical study. Patients were to have a stable knee joint or be a candidate for joint stabilization within 12 weeks of the procedure, an International Cartilage Repair Society (ICRS) classification ≤ 2, and no more than 3 prior surgeries on the index knee. Post-implantation, clinical efficacy was assessed at each follow-up visit based on the following patient-reported outcome scores: Visual Analogue Scale (VAS) score for pain, and both the Knee and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) score for function. Preliminary efficacy data are available for 48/52 patients at 3 months follow-up and 35/52 patients at 6 months follow-up. Full data, including 12 months follow-up for all available patients will be presented.

Results: Compared to the mean baseline values, a statistically significant reduction in post-operative knee pain was reported based on VAS both at 3 and 6 months. Statistically significant improvements compared to baseline were also reported in IKDC scores and all components of the KOOS questionnaire both at 3 and 6 months post implantation.

Conclusions: These promising clinical results clearly illustrate the early efficacy of this novel meniscus implant for partial meniscus tissue loss. Longer follow-up is however needed to establish its full potential.