在髋关节半关节成形术治疗移位的囊内骨折中,改良的肌肉疏松后路技术与标准侧路相比的临床效果(HemiSPAIRE):一项多中心、平行组、随机对照试验。

IF 2.1 Q2 SURGERY BMJ Surgery Interventions Health Technologies Pub Date : 2024-06-17 eCollection Date: 2024-01-01 DOI:10.1136/bmjsit-2023-000251
Susan Ball, Alex Aylward, Emma Cockcroft, Aisling Corr, Elizabeth Gordon, Alison Kerridge, Amy McAndrew, Sarah Morgan-Trimmer, Roy Powell, Anna Price, Shelley Rhodes, Andrew John Timperley, Jayden van Horik, Robert Wickins, John Charity
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引用次数: 0

摘要

目标与标准侧方入路相比,评估在髋关节半关节成形术治疗移位的囊内骨折时采用改良的后方肌肉疏松入路 SPAIRE(拯救腓肠肌和内侧肌,修复外侧肌)对术后活动度和功能的影响:设计:实用性、优越性、多中心、平行组、随机对照试验(内部试点)。参试者、病房工作人员和进行术后评估的研究人员均为分配盲人。CTU使用计算机生成的名单集中分配治疗:地点:英格兰西南部六家医院,招募时间:2019年11月25日-2022年4月25日.参与者:244名需要进行髋关节半置换术的成人(≥60岁)(每种方法各分配122人)。分别有90名和85名分配到SPAIRE和侧位的参与者在预先指定的数据收集窗口内获得了主要结果数据:干预措施:采用 SPAIRE 或标准侧位方法进行手术。术后 3 天和 120 天随访:主要结果测量:牛津髋关节评分(OHS),120 天时通过电话进行。次要结果:功能和活动能力(3天)、疼痛(3天、120天)、出院目的地、住院时间、并发症和死亡率(120天内)、生活质量和居住地(120天):参与者的平均年龄为 84.6 岁(SD 7.2);168 人(69%)为女性。主要结果:几乎没有证据表明 120 天后的 OHS 存在差异;调整后的平均差异(SPAIRE-侧)为-1.23(95% CI -3.96 至 1.49,P=0.37)。次要结果:SPAIRE治疗组3天时参与者报告的疼痛程度较低;其余结果治疗组之间无差异:无论采用 SPAIRE 还是侧位方法,受试者在短期(3 天)和长期(120 天)内的活动能力和功能相似。在住院时间、恢复到骨折前的居住状态、120天内的存活率或120天后的生活质量方面,两种方法都没有优势。接受SPAIRE入路的患者在术后早期的疼痛可能较轻。将髋关节半关节置换术中的后方入路改为SPAIRE入路,120天内患者的疗效与侧方入路相当:试验注册号:NCT04095611。
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Clinical effectiveness of a modified muscle sparing posterior technique compared with a standard lateral approach in hip hemiarthroplasty for displaced intracapsular fractures (HemiSPAIRE): a multicenter, parallel-group, randomized controlled trial.

Objectives: Assess the effect of a modified muscle sparing posterior approach; SPAIRE (Save Piriformis and Internus, Repairing Externus), in hip hemiarthroplasty for displaced intracapsular fractures on postoperative mobility and function compared with a standard lateral approach.

Design: Pragmatic, superiority, multicenter, parallel-group, randomized controlled trial (with internal pilot). Participants, ward staff, and research staff conducting postoperative assessments were blinded to allocation. A CTU allocated treatments centrally using computer-generated lists.

Setting: Six hospitals in Southwest England, recruiting November 25, 2019-April 25, 2022.

Participants: 244 adults (≥60 years) requiring hip hemiarthroplasty (122 allocated to each approach). 90 and 85 participants allocated to SPAIRE and lateral, respectively, had primary outcome data within the prespecified data collection window.

Interventions: Surgery using SPAIRE or standard lateral approach. Follow-up 3 days and 120 days postoperation.

Main outcome measure: Oxford Hip Score (OHS), via telephone at 120 days. Secondary outcomes: function and mobility (3 days), pain (3 days, 120 days), discharge destination, length of hospital stay, complications and mortality (within 120 days), quality of life and place of residence (120 days).

Results: Participants' mean age was 84.6 years (SD 7.2); 168 (69%) were women. Primary outcome: little evidence of a difference in OHS at 120 days; adjusted mean difference (SPAIRE-lateral) -1.23 (95% CI -3.96 to 1.49, p=0.37). Secondary outcomes: indication of lower participant-reported pain at 3 days in SPAIRE arm; no differences between arms for remaining outcomes.

Conclusions: Participants' mobility and function are similar in the short term (3 days) and longer term (120 days), whether receiving the SPAIRE or lateral approach. Neither approach confers benefit over the other in terms of length of hospital stay, return to prefracture residence, survival within 120 days, or quality of life at 120 days. Participants receiving SPAIRE approach may experience less pain in the early postoperative period. Modifying the posterior approach in hip hemiarthroplasty to the SPAIRE approach gives equivalent patient outcomes to the lateral approach within 120 days.

Trial registration number: NCT04095611.

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来源期刊
CiteScore
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发文量
22
审稿时长
17 weeks
期刊最新文献
The impact of adjuvant antibiotic hydrogel application on the primary stability of uncemented hip stems. Prospective randomized evaluation of the sustained impact of assistive artificial intelligence on anesthetists' ultrasound scanning for regional anesthesia. Clinical effectiveness of a modified muscle sparing posterior technique compared with a standard lateral approach in hip hemiarthroplasty for displaced intracapsular fractures (HemiSPAIRE): a multicenter, parallel-group, randomized controlled trial. IDEAL evaluation for global surgery innovation. No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework.
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