髋关节手术技术增强康复(HIPSTER):一项单中心、双盲、平行三臂、随机对照、优势试验。

IF 3.1 Q1 ORTHOPEDICS
Holly Whitmore, Alison Smeatham, Siobhan Creanor, Fiona C Warren, Sarah L Whitehouse, Elizabeth Gordon, Timothy P Holsgrove, A M Kassam, A John Timperley, Chris Hayward, Heather Cook, Lucy Clarke, Paul Winspear, Peter Greenstreet, Peter Tippett, Phoebe Dawe, Rebecca Barnard, Rebeka Sultana
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引用次数: 0

摘要

目的:本试验的主要目的是研究与机器人辅助的标准后路手术(PA)相比,两种新型机器人辅助的保留肌腱后路全髋关节置换术(THA)手术,梨状肌-保留后路(PSPA)和备用梨状肌-内肌修复外路技术(SPAIRE)是否能改善THA患者的早期预后。方法:髋关节外科技术增强康复(HIPSTER)是一项单中心、双盲、平行三臂、随机对照的优势试验。共有309名18岁以上已列入选择性THA的参与者将被招募。参与者将按1:1:1的比例随机分配到SPAIRE:PSPA:PA,使用最小化(随机元素)的性别(男性;女性),年龄(< 50岁;≥50岁)和BMI (< 30 kg/m2;≥30 kg/m2)。主要结果是患者报告的牛津关节置换术早期恢复评分(OARS),在手术后6周评估。次要结果测量包括血液生物标志物、活动监测和患者报告的结果测量。结论:该试验将评估两种新型机器人辅助的保留肌腱后路THA手术,PSPA和SPAIRE,与机器人辅助的标准PA相比,是否能改善THA患者的预后。如果成功,预计该试验的结果将为计划未来的多中心随机对照试验提供必要的证据,以比较该疗效试验中确定的最佳肌腱保留方法(PSPA或SPAIRE)与金标准PA,以评估疗效结果是否可在整个NHS中推广。在提交时,该试验目前正在完成招募,后续工作将于2026年完成。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

HIP Surgical Techniques to Enhance Rehabilitation (HIPSTER) : a single-centre, double-blind, parallel three-arm, randomized-controlled, superiority trial.

HIP Surgical Techniques to Enhance Rehabilitation (HIPSTER) : a single-centre, double-blind, parallel three-arm, randomized-controlled, superiority trial.

HIP Surgical Techniques to Enhance Rehabilitation (HIPSTER) : a single-centre, double-blind, parallel three-arm, randomized-controlled, superiority trial.

Aims: The primary aim of this trial is to investigate whether two novel robotic-assisted tendon-sparing posterior approaches to total hip arthroplasty (THA) surgery, the piriformis-sparing posterior approach (PSPA) and the spare piriformis and internus, repair externus technique (SPAIRE), improve early patient outcomes in THA compared with a robotic-assisted standard posterior approach (PA).

Methods: HIP Surgical Techniques to Enhance Rehabilitation (HIPSTER) is a single-centre, double-blind, parallel three-arm, individually randomized, controlled, superiority trial. A total of 309 participants aged over 18 years who have been listed for an elective THA will be recruited. Participants will be randomized in a 1:1:1 ratio to SPAIRE:PSPA:PA, using minimization (with a random element) on sex (males; females), age (< 50 years; ≥ 50 years), and BMI (< 30 kg/m2; ≥ 30 kg/m2). The primary outcome is the patient-reported outcome of Oxford Arthroplasty Early Recovery Score (OARS), assessed six weeks after surgery. Secondary outcome measures include blood biomarkers, activity monitoring, and patient-reported outcome measures.

Conclusion: The trial will assess whether the two novel robotic-assisted tendon-sparing posterior approaches to THA surgery, the PSPA and SPAIRE, improve patient outcomes in THA compared with a robotic-assisted standard PA. If successful, it is anticipated that the results of this trial will provide the evidence necessary to plan a future multicentre, randomized-controlled trial to compare the best-performing tendon-sparing approach (PSPA or SPAIRE) identified in this efficacy trial with the gold standard PA, to assess whether the efficacy results are generalizable across the NHS. At the time of the submission, the trial is currently completing recruitment, and the follow-up will be completed in 2026.

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来源期刊
Bone & Joint Open
Bone & Joint Open ORTHOPEDICS-
CiteScore
5.10
自引率
0.00%
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0
审稿时长
8 weeks
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