双相骨软骨支架治疗轻中度膝关节骨关节炎的两年临床结局
简介
该研究纳入8例轻中度膝骨关节炎（Kellgren-Lawrence 1-3级，无>5°内外翻畸形）患者，平均年龄53.9岁，采用双相骨软骨支架修复局灶性软骨缺损（平均面积4.5 cm²）。术后2年随访显示，KOOS、IKDC及VAS评分均较术前显著改善，MOCART评分变化与功能评分平行，且无严重不良事件。初步证实该支架在轻中度OA患者中安全可行，为开展更大…
英文摘要
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 1-3 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.