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

BACKGROUND: Chondral/osteochondral knee lesions are commonly encountered and often associated with progression of osteoarthritis (OA). Nevertheless, knee repair trials have traditionally excluded patients with concurrent mild to moderate OA. PURPOSE: To compare the clinical and safety outcomes of knee repair with an aragonite-based osteochondral implant with outcomes of surgical standard of care (SSOC) in patients with chondral/osteochondral knee lesions, including those with mild to moderate OA. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: , bony defect depth ≤8 mm, and Kellgren-Lawrence knee OA score of 0 to 3. Patients were randomized 2:1 to receive an aragonite-based implant or SSOC (arthroscopic debridement or microfracture) and followed for 5 years. The primary endpoint was improvement in overall Knee injury and Osteoarthritis Outcome Score (KOOS). Secondary endpoints included percentage of responders (minimum overall KOOS improvement ≥ 30 points), patient-reported outcomes (KOOS subscale values and International Knee Documentation Committee subjective score), treatment failure (ie, need for any secondary treatment), and treatment-emergent adverse events. A covariate analysis compared primary/secondary outcomes between patients with no to minimal and mild to moderate OA. RESULTS: < .001) than the SSOC group. CONCLUSION: The results confirmed that the aragonite-based scaffold is both safe and superior to SSOC in improving clinical outcomes at up to 5 years' evaluation, as well as in patients with mild to moderate OA.