MoRe Foundation, Antwerp, Belgium.
Antwerp University, Antwerp, Belgium.
Cartilage. 2021 Dec;13(1_suppl):1217S-1227S. doi: 10.1177/1947603520988164. Epub 2021 Jan 15.
The study aimed to evaluate the clinical outcome and repair capacity of a cell-free aragonite-based scaffold in patients with an isolated symptomatic joint surface lesion (JSL) of the knee.
Thirteen patients (age 33.5 ± 8.9; female 23%; body mass index 25.3 ± 3.4, K/L [Kellgren-Lawrence] 1.8) with a JSL (2.6 ± 1.7 cm [1.0-7.5 cm]) of the distal femur were enrolled in a single-center prospective case series. Safety and clinical outcome was assessed by the KOOS (Knee Injury and Osteoarthritis Outcome Score), IKDC (International Knee Documentation Committee), Lysholm, and Tegner activity scale at baseline and 6, 12, 18, 24, and 36 months follow-up. The MOCART 2.0 and scaffold integration were evaluated on magnetic resonance imaging at 12, 24, and 36 months postoperatively.
Primary outcome (KOOS pain) improved with 36.5 ± 14.7 points at 12 months ( = 0.002) and 41.2 ± 14.7 points at 36 months ( = 0.002) follow-up. Similar increasing trends were observed for the other KOOS subscales, IKDC, and Lysholm score, which were significantly better at each follow-up time point relative to baseline ( < 0.05). Activity level increased from 2.75 ± 1.6 to 4.6 ± 2.2 points at final follow-up ( = 0.07). The MOCART was 61.7 ± 12.6 at 12 months and 72.9 ± 13.0 at 36 months postoperatively. Sixty-six to 100% implant integration and remodeling was observed in 73.3% cases at 36 months. No serious adverse events were reported.
The study demonstrated that the biphasic aragonite-based scaffold is a safe and clinically effective implant for treating small-medium sized JSLs of the distal femur in a young and active patient cohort. The implant showed satisfying osteointegration and restoration of the osteochondral unit up to 3 years postimplantation.
本研究旨在评估一种无细胞方解石基支架在膝关节孤立性关节表面病变（JSL）患者中的临床疗效和修复能力。
本研究纳入了 13 名（年龄 33.5 ± 8.9 岁；女性占 23%；体重指数 25.3 ± 3.4，K/L [Kellgren-Lawrence] 1.8）存在股骨远端 JSL（2.6 ± 1.7 cm [1.0-7.5 cm]）的患者，进行单中心前瞻性病例系列研究。通过 KOOS（膝关节损伤和骨关节炎评分）、IKDC（国际膝关节文献委员会）、Lysholm 和 Tegner 活动量表在基线和 6、12、18、24 和 36 个月随访时评估安全性和临床结果。在术后 12、24 和 36 个月时通过 MOCART 2.0 和支架整合情况进行磁共振成像评估。
主要结局（KOOS 疼痛）在 12 个月时改善了 36.5 ± 14.7 分（ = 0.002），在 36 个月时改善了 41.2 ± 14.7 分（ = 0.002）。其他 KOOS 亚量表、IKDC 和 Lysholm 评分也呈现出类似的增加趋势，在每个随访时间点与基线相比均有显著改善（ < 0.05）。活动水平从基线时的 2.75 ± 1.6 分增加到最终随访时的 4.6 ± 2.2 分（ = 0.07）。术后 12 个月时的 MOCART 为 61.7 ± 12.6，术后 36 个月时为 72.9 ± 13.0。在 36 个月时，66%至 100%的植入物整合和重塑在 73.3%的病例中观察到。未报告严重不良事件。
本研究表明，双相方解石基支架是一种安全且临床有效的植入物，可用于治疗年轻、活跃患者的股骨远端中小面积 JSL。植入物在植入后 3 年内表现出令人满意的骨整合和修复。
