Department of Orthopedic Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
BMC Musculoskelet Disord. 2023 Jan 26;24(1):69. doi: 10.1186/s12891-023-06177-4.
The rationale for gradually reducing radius (GR) femoral component aims to prevent flexion instability by gradually change the center of femoral rotation, unlike a discrete change by the multi-radius (MR) which is more common for most of total knee arthroplasties (TKA). However, no strong evidence has been reported the clinical significance of the GR design.
This patient-blinded, parallel, non-inferiority trial conducted between January 2018-December 2020. Patients with knee osteoarthritis consented for cruciate retaining TKA were randomly allocated to a GR or MR group. Primary outcome measures were knee functions at postoperative 6 and 12 months using the Knee injury and Osteoarthritis Outcome Score (KOOS). Secondary outcome measures were performance-based tests (30-s chair stand test, 40-m fast paced walk test, and 3-m timed up and go test), and knee motions.
Sixty patients were enrolled and randomized; GR (n = 30) and MR (n = 30) group. The changes of KOOS at 6 and 12 months from baseline showed clinical meaningful for both GR and MR group. At 6 and 12 months postoperatively, there was no significant difference between both groups in all KOOS subscales. The length of stay was not different between GR and MR group (5.93 ± 1.44 vs 6.17 ± 1.86 days, p = 0.59). Patients on both groups presented similar performance-based tests. However, the improvement in degrees of knee motion for the GR group was significantly greater than the MR group (34.67 ± 12.52 vs 23.67 ± 12.59, p = 0.001).
GR was noninferiority to MR for the functional outcomes and performances after TKA. The GR femoral component gave more knee motions than did the MR prostheses.
Level I, therapeutic study.
逐渐减小股骨半径(GR)的设计理念旨在通过逐渐改变股骨旋转中心来预防屈曲不稳定,而不是像多半径(MR)那样发生离散变化,后者在大多数全膝关节置换术(TKA)中更为常见。然而,目前还没有强有力的证据表明 GR 设计的临床意义。
这是一项患者盲法、平行、非劣效性试验,于 2018 年 1 月至 2020 年 12 月进行。患有膝关节骨关节炎并同意接受保留交叉韧带的 TKA 的患者被随机分配到 GR 或 MR 组。主要观察指标为术后 6 个月和 12 个月时膝关节功能的 Knee injury and Osteoarthritis Outcome Score(KOOS)评分。次要观察指标为基于表现的测试(30 秒坐立测试、40 米快走测试和 3 米计时起立行走测试)和膝关节运动。
共纳入并随机分配 60 名患者;GR(n=30)和 MR(n=30)组。从基线到术后 6 个月和 12 个月,KOOS 的变化在 GR 和 MR 两组均具有临床意义。术后 6 个月和 12 个月,两组在所有 KOOS 亚组之间均无显著差异。GR 和 MR 组的住院时间无差异(5.93±1.44 天 vs 6.17±1.86 天,p=0.59)。两组患者的基于表现的测试结果相似。然而,GR 组的膝关节运动角度改善明显大于 MR 组(34.67±12.52° vs 23.67±12.59°,p=0.001)。
GR 在 TKA 后的功能结果和表现方面不劣于 MR。GR 股骨组件比 MR 假体提供了更多的膝关节运动。
I 级,治疗性研究。