Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial

Altschuler N, Zaslav KR, Di Matteo B, et al. · The American Journal of Sports Medicine

At 24 months the implant group had roughly twice the mean KOOS improvement, a 77.8% responder rate vs 33.6% for control, 88.5% vs 30.9% defect fill on MRI, and 7.2% vs 21.4% failure. Basis of the 2022 FDA approval.

Population

251 patients with knee chondral/osteochondral lesions, including knees with mild-to-moderate OA (167 implant, 84 control), at 26 sites

Intervention

Agili-C aragonite-based scaffold implantation

Comparator

Surgical standard of care (debridement or microfracture at surgeon's discretion)

Limitations

Sponsor (CartiHeal)-run pivotal trial; open-label; control arm mixed debridement with microfracture; 2:1 randomization.