Abstract

A biphasic osteochondral construct has been developed to repair focal chondral and osteochondral lesions. This study aimed to evaluate the safety and preliminary clinical feasibility of using the biphasic osteochondral construct in treating patients having mild-to-moderate-stage knee osteoarthritis. This single-center, prospective, open-label, single-arm feasibility trial compared 2-year knee functional outcome (KOOS and IKDC scores), pain VAS score, and radiological assessment of repaired cartilage (MOCART score) after treatment versus the corresponding preoperative scores. All enrolled patients had a clinical history of primary knee osteoarthritis (OA), Kellgren Lawrence grade 13 without valgus or varus deformity greater than 5 degrees. Five men and three women completed the two-year follow-up, with a mean age of 53.9 ± 9.3 years (range 34–63 years). The average lesion size was 4.5 ± 2.9 cm2 (range 2–9 cm2). The patients received one to three biphasic osteochondral constructs. No major adverse effects or complications were reported postoperatively. The mean KOOS subscale values, VAS scores, and IKDC scores were all improved significantly at six months post operation and were maintained for two years. The changes in MOCART scores of the regenerated cartilage were parallel to the changes observed in KOOS values. Our findings provide preliminary evidence of the safety and clinical feasibility of using biphasic osteochondral constructs to treat focal chondral and osteochondral lesions in patients with mild- or moderate-stage osteoarthritis, and support the rationale for larger controlled trials.

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