Five-Year Follow-up of a Multicenter Randomized Controlled Trial Comparing an Aragonite-Based Scaffold With Microfracture and Debridement for Chondral and Osteochondral Knee Lesions

Altschuler N, Kon E, et al. · The American Journal of Sports Medicine

At 60 months the implant group maintained superiority: KOOS 81.0 vs 59.1 (22.6-point difference), responder rate 74.7% vs 29.6%, treatment failure 15.0% vs 35.7% (P < .001). Note implant failures roughly doubled between years 2 and 5 (7.2% to 15.0%).

Population

5-year follow-up of the 251-patient pivotal RCT cohort

Intervention

Agili-C aragonite-based scaffold

Comparator

Surgical standard of care (debridement/microfracture)

Limitations

Sponsor-funded extension; open-label; attrition over 5 years; control arm degraded as expected for microfracture, flattering the contrast.