Two-year clinical results of a novel load redistribution device for the treatment of medial knee OA.

ABSTRACT

PURPOSE: A potential method to relieve the pain from medial osteoarthritis of the knee is to offload the medial compartment. The Latella™ Knee Implant is a novel device designed to offload the medial compartment. The objective of the Cotera-1 study was to evaluate the preliminary safety and feasibility of the Latella implant to treat patients with medial OA of the knee, by a 2-year follow-up of a prospective multicenter feasibility study (Cotera-1) performed in the Netherlands and UK METHODS: In this first-in-man study, 11 participants received the Latella implant and were followed for 2 years, documenting physician assessment, Patient-Reported Outcome (PRO) scoring (KOOS, IKDC, Kujala, SF-36); Patient Global Assessment (PGA), radiographic analysis and MRI analysis, complications, reoperation rate and hip-knee-ankle axis. RESULTS: The Latella Knee Implant system proved to be well tolerated and demonstrated a low-risk safety profile up to 24 months post-treatment. A responder analysis was performed of the subjects who still had the Latella implanted at 24-month time point (n = 9). Based on a MCID of eight for KOOS pain sub-scale, 78% of the subjects at the 24 month time point would be considered as responders. Similarly, based on improvement in the medial knee pain compared to baseline using the NRS scale of 1-10, 89% of the subjects at the 24-month time point would be considered as responders. Two patients were revised during follow-up one for arthrofibrosis and one converted to TKA for progression of OA. CONCLUSIONS: The early clinical experience with the Latella Knee Implant in this pilot feasibility study has been encouraging. It appears to be a safe implant with possible effect on medial OA. Additional studies need to be performed to assess the safety and efficacy of the procedure in a larger patient population. LEVEL OF EVIDENCE II.