Purpose: This study compared the efficacy and safety of Characterized Chondrocyte Implantation (CCI) to microfracture in the repair of symptomatic cartilage defects of the femoral condyle.

Methods: CCI (n=51) was compared to microfracture (n=61) in patients with grade III–IV symptomatic cartilage defects of the femoral condyles in a prospective, multicenter, randomized, controlled trial. Structural repair was assessed at 1 year by histopathologists blinded to the treatment using

computerized histomorphometry and

Results: CCI resulted in better structural repair than microfracture at 1 year post-treatment, as assessed by histomorphometry (p=0.003) and overall histology (p=0.012). Structural repair parameters relating to chondrocyte phenotype and tissue structure were also superior with CCI. Noninferiority of CCI was demonstrated for clinical outcome at 12–18 months, and both treatments were generally well tolerated.

Conclusion: At 1 year post-treatment, CCI resulted in superior tissue repair compared to microfracture. Short-term clinical outcome after 12–18 months was similar for both treatments, as was the safety profile. The superior structural repair achieved with CCI may lead to improved long-term clinical benefits.