In a propensity score matched pair analysis using data from two phase III studies, M-ACI with an in-situ cross-linking hydrogel as chondrocyte carrier (NOVOCART® Inject plus) was compared to MFx in patients with focal knee cartilage defects.
The propensity score was estimated using the preoperative KOOS, duration of symptoms, previous knee surgeries, age and sex using a logistic regression model, resulting in 144 patients in the matched pair set (72 per group). The primary endpoint was the change in total KOOS from baseline to the 24-month assessment.
Both groups were comparable regarding baseline KOOS, gender, age, body-mass index, duration of symptoms, smoking status and previous knee surgeries. Individual defect sizes in the M-ACI group were significantly larger than in the MFx group (4.8 cm2 vs. 3.4 cm2). Further differences concerned defect location (no patellar or tibial defects in MFx), number of defects (M-ACI group: 33.3 % with two defects vs. MFx: 9.7%) and defect etiology (more patients with degenerative lesions in the M-ACI group). Both the absolute KOOS and the KOOS changes from baseline at 24 months were higher in the M-ACI group (absolute KOOS: M-ACI 81.8 ± 16.8 vs. MFx 73.0 ± 20.6, KOOS change: M-ACI 40.1 ± 19.5 vs. MFx 30.6 ± 26.1). Treatment contrasts indicated statistically significant superiority of M-ACI from Month 3 up to Month 24 (p = 0.0026). Significant and clinically meaningful differences in favor of M-ACI at 24 months were also found for IKDC changes from baseline (37.8 points vs. 30.4 points, p = 0.0334), KOOS (94.4% vs. 65.3%, p <0.0001) and IKDC responder rates (83.3% vs. 61.1%, p = 0.0126).
In this explorative analysis, M-ACI with NOVOCART® Inject plus has demonstrated superior clinical outcomes compared to MFx in patients with knee cartilage defects during the 2-years follow-up.