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逐渐减小半径与多半径全膝关节置换术的临床优势:一项非劣效性随机试验。

Clinical advantages of gradually reducing radius versus multi-radius total knee arthroplasty: a noninferiority randomized trial.

机构信息

Department of Orthopedic Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.

出版信息

BMC Musculoskelet Disord. 2023 Jan 26;24(1):69. doi: 10.1186/s12891-023-06177-4.

DOI:10.1186/s12891-023-06177-4
PMID:36703203
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9878805/
Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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).

CONCLUSION

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 OF EVIDENCE

Level I, therapeutic study.

摘要

背景

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。

方法

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。

结果

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)。

结论

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。

证据水平

I 级,治疗性研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2bc/9878805/ff77382a15ed/12891_2023_6177_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2bc/9878805/d0dc50f51174/12891_2023_6177_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2bc/9878805/88d69f8d987d/12891_2023_6177_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2bc/9878805/38e82299c991/12891_2023_6177_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2bc/9878805/ff77382a15ed/12891_2023_6177_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2bc/9878805/d0dc50f51174/12891_2023_6177_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2bc/9878805/88d69f8d987d/12891_2023_6177_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2bc/9878805/38e82299c991/12891_2023_6177_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2bc/9878805/ff77382a15ed/12891_2023_6177_Fig4_HTML.jpg

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