Abstract
OBJECTIVE: To prospectively assess the efficacy of GelrinC in the treatment of chondral and osteochondral femoral cartilage lesions using morphological (Magnetic Resonance Observation of Cartilage Repair Tissue [MOCART]) and quantitative (T(2)-mapping) magnetic resonance imaging (MRI). DESIGN: This study was designed as a prospective single-arm, open label, multicenter study. Morphological magnetic resonance imaging (MRI) for MOCART assessment and T(2) mapping was performed 1 week and 6, 12, 18, and 24 months after GelrinC implantation. Evaluation of T(2) mapping was based on the assessment of global T(2) indices (T(2) of the repair tissue [RT] divided by T(2) of healthy reference cartilage) and zonal variation. RESULTS: Fifty-six (20 female) patients were prospectively enrolled. The mean MOCART score significantly increased from baseline to the 24-month follow-up with 88.8 (95% CI, 85.8-91.9; P < 0.001) for all lesions combined as well as 86.8 (95% CI, 83.0-90.6) for chondral lesions and 94.1 (95% CI, 68.55-100) for osteochondral lesions. Furthermore, based on T(2) mapping, significant zonal variation of the RT was observed at 24 months (P = 0.039), which did not differ significantly from healthy reference cartilage (P = 0.6). CONCLUSION: Increasing MOCART scores were observed throughout the follow-up period, indicative of maturation of the cartilage repair. Significant zonal variation of the RT at 24 months might indicate the transformation into hyaline cartilage-like RT. Slightly differing morphological outcome between chondral and osteochondral lesions, but similar global and zonal T(2) indices at 24 months, support the potential of GelrinC as a treatment option for both lesion types.