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直接前入路与小切口后外侧入路全髋关节置换术的随机临床试验:7.5 年随访时小的、早期的功能差异并未导致有意义的临床差异。

A Randomized Clinical Trial of Direct Anterior Versus Mini-Posterior Total Hip Arthroplasty: Small, Early Functional Differences Did Not Lead to Meaningful Clinical Differences at 7.5 Years.

机构信息

Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota.

Division of Clinical Trials and Biostatistics, Department of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota.

出版信息

J Arthroplasty. 2024 Sep;39(9S1):S97-S100. doi: 10.1016/j.arth.2024.05.016. Epub 2024 May 11.

Abstract

BACKGROUND

Our previously reported randomized clinical trial of direct anterior approach (DAA) versus mini-posterior approach (MPA) total hip arthroplasty showed slightly faster initial recovery for patients who had a DAA and no differences in complications or clinical or radiographic outcomes beyond 8 weeks. The aims of the current study were to determine if early advantages of DAA led to meaningful clinical differences beyond 5 years and to identify differences in midterm complications.

METHODS

Of the 101 original patients, 93 were eligible for follow-up at a mean of 7.5 years (range, 2.1 to 10). Clinical outcomes were compared with Harris Hip, 12-Item Short Form Health Survey, and Hip Disability and Osteoarthritis Outcomes Scores (HOOS) scores and subscores, complications, reoperations, and revisions.

RESULTS

Harris Hip scores were similar (95.3 ± 6.0 versus 93.5 ± 10.3 for DAA and MPA, respectively, P = .79). The 12-Item Short Form Health Survey physical and mental scores were similar (46.2 ± 9.3 versus 46.2 ± 10.6, P = .79, and 52.3 ± 7.1 versus 55.2 ± 4.5, P = .07 in the DAA and MPA groups, respectively). The HOOS scores were similar (97.4 ± 7.9 versus 96.3 ± 6.7 for DAA and MPA, respectively, P = .07). The HOOS quality of life subscores were 96.9 ± 10.8 versus 92.3 ± 16.0 for DAA and MPA, respectively (P = .046). No clinical outcome met the minimally clinically important difference. There were 4 surgical complications in the DAA group (1 femoral loosening requiring revision, 1 dislocation treated closed, and 2 wound dehiscences requiring debridement), and 6 surgical complications in the MPA group (3 dislocations, 2 treated closed, and 1 revised to dual mobility; 2 intraoperative fractures treated with a cable; and 1 wound dehiscence treated nonoperatively).

CONCLUSIONS

At a mean of 7.5 years, this randomized clinical trial demonstrated no clinically meaningful differences in outcomes, complications, reoperations, or revisions between DAA and MPA total hip arthroplasty.

LEVEL OF EVIDENCE

IV.

摘要

背景

我们之前报道的直接前路(DAA)与小切口后路(MPA)全髋关节置换术的随机临床试验显示,DAA 组患者的初始恢复稍快,但在 8 周后并发症、临床或影像学结果无差异。本研究的目的是确定 DAA 的早期优势是否会在 5 年以上产生有意义的临床差异,并确定中期并发症的差异。

方法

在最初的 101 名患者中,93 名符合随访条件,平均随访时间为 7.5 年(范围:2.1 至 10 年)。通过 Harris 髋关节评分、12 项简明健康调查量表(SF-12)和髋关节残疾和骨关节炎结果评分(HOOS)评分及其亚评分比较临床结果,评估并发症、再次手术和翻修情况。

结果

Harris 髋关节评分相似(DAA 组为 95.3±6.0,MPA 组为 93.5±10.3,P=0.79)。12 项简明健康调查量表的生理和心理评分相似(DAA 组为 46.2±9.3,MPA 组为 46.2±10.6,P=0.79;DAA 组为 52.3±7.1,MPA 组为 55.2±4.5,P=0.07)。HOOS 评分相似(DAA 组为 97.4±7.9,MPA 组为 96.3±6.7,P=0.07)。HOOS 生活质量亚评分相似(DAA 组为 96.9±10.8,MPA 组为 92.3±16.0,P=0.046)。没有任何临床结果达到最小临床重要差异。DAA 组有 4 例手术并发症(1 例股骨松动需要翻修,1 例脱位经闭合治疗,2 例切口裂开需要清创),MPA 组有 6 例手术并发症(3 例脱位,2 例经闭合治疗,1 例改为双动;2 例术中骨折用电缆固定;1 例切口裂开非手术治疗)。

结论

在平均 7.5 年的随访中,这项随机临床试验表明,直接前路与小切口后路全髋关节置换术在结果、并发症、再次手术或翻修方面没有临床意义上的差异。

证据水平

IV 级。

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