IMPLANTATION OF CHONDROCELECT® LEADS TO SIGNIFICANT CLINICAL BENEFIT AT 36 MONTHS POST-SURGERY AS COMPARED TO MICROFRACTURE

Abstract

Purpose: Long-term follow-up was to determine clinical benefit of ChondroCelect (CC) in the repair of full-thickness femoral cartilage lesions as compared to microfracture (MF).

Methods: In a randomized controlled clinical trial CC (n=57) was compared to MF (n=61) in patients aged 18 to 50 years with single ICRS grade III/IV symptomatic cartilage defects of the femoral condyles. Clinical improvement was measured up to 36 months using the KOOS (Knee injury and Osteoarthritis Outcome Score). Safety was monitored throughout the study.

Results: At baseline, KOOS was comparable between treatment groups (Mean ± SD: CC, 56.30 ± 13.61 and MF, 59.53 ± 14.95). Improvement from baseline in adjusted mean ± SE for the Overall KOOS was 21.25 ± 3.60 for the CC group vs. 15.83 ± 3.48 for the MF group at 36 months. When using the mixed linear model analysis at 36 months, statistically significantly greater improvements were demonstrated in the CC group vs. the MF group in change from baseline for the overall KOOS (D 7.60%, P = 0.018), as well as in 4 of 5 KOOS domains (activities of daily living, pain, symptoms/stiffness, and quality of life). Percentages of treatment responders were 83% (n = 34/41) vs. 62% (n = 31/50) based on the KOOS for CC and MF groups, respectively. Two (3.9%) patients in the CC group and 7 (11.5%) patients in the MF group underwent a re-intervention and were therefore considered treatment failures. Both treatments were well tolerated and the proportion of patients reporting AEs diminished over time, indicating stabilization of the patients’ condition.

Conclusions: Implantation of ChondroCelect in the treatment of articular cartilage defects of the femoral condyles shows superior clinical benefit at 36 months vs. microfracture. Structural superiority in favour of the ChondroCelect group was previously demonstrated at 1 year follow up.