There is a strong unmet need for a solution that will relieve post-meniscectomy pain. Purpose of this first-in-man study was to evaluate the safety and clinical performance of an anatomical medial meniscus prosthesis.
A first-in-man, prospective, multi-centre, single arm clinical investigation included 5 post-medial meniscectomy syndrome patients with limited underlying cartilage damage and a normal lateral compartment. The polycarbonate urethane medial meniscus prosthesis which was clicked onto two titanium screws fixated at the native horn attachments on the tibia. KOOS was collected at baseline and at 6 weeks, 3, 6, 12 and 24 months and MRI scans at 12 and 24 months.
The surgical technique was demonstrated feasible and reproducable. Positioning of the posterior screw is crucial for correct positioning of the prosthesis. All patients reached the 6 months evaluationon which all patients reported knee joint stiffness and slight effusion. In three patients the implants were removed because of implant failure and in one patient the implant was removed because of persistent pain and extension deficit. In all patients the KOOS score did not improve in the first 6 months after surgery till the implants were removed. The explantations of the implants demonstrated no articular cartilage damage and the fixation screws were securely anchored. One patient still has the implant in situ. In this patient all PROMs started to improve 1 year after surgery and this improvement continued onto 2 years follow up.
This is the first clinical study with an anatomical meniscus prosthesis. One out of five patients showed good clinical results after two years. The other four implants needed to be removed due to failure or discomfort of the patient. Currently the design and surgical technique were changed and will be subject the a first-in-man study.