Ball Susan, Aylward Alex, Cockcroft Emma, Corr Aisling, Gordon Elizabeth, Kerridge Alison, McAndrew Amy, Morgan-Trimmer Sarah, Powell Roy, Price Anna, Rhodes Shelley, Timperley Andrew John, van Horik Jayden, Wickins Robert, Charity John
NIHR Applied Research Collaboration South West Peninsula (PenARC), Department of Health and Community Sciences, University of Exeter Faculty of Health and Life Sciences, Exeter, UK.
NIHR Applied Research Collaboration South West Peninsula (PenARC), Patient Engagement Group, University of Exeter Faculty of Health and Life Sciences, Exeter, UK.
BMJ Surg Interv Health Technol. 2024 Jun 17;6(1):e000251. doi: 10.1136/bmjsit-2023-000251. eCollection 2024.
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.
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.
Six hospitals in Southwest England, recruiting November 25, 2019-April 25, 2022.
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.
Surgery using SPAIRE or standard lateral approach. Follow-up 3 days and 120 days postoperation.
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).
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.
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.
NCT04095611.
评估改良的保留肌肉后入路（SPAIRE，即保留梨状肌和闭孔内肌，修复闭孔外肌）在髋关节半关节置换术治疗囊内移位骨折时，与标准外侧入路相比，对术后活动能力和功能的影响。
实用、优效性、多中心、平行组、随机对照试验（含内部预试验）。进行术后评估的参与者、病房工作人员和研究人员对分组情况不知情。一个临床试验单位使用计算机生成的列表集中分配治疗方案。
英格兰西南部的六家医院，招募时间为2019年11月25日至2022年4月25日。
244名成年人（≥60岁）需要进行髋关节半关节置换术（每种入路分配122名）。分别分配到SPAIRE组和外侧入路组的90名和85名参与者在预定的数据收集窗口内有主要结局数据。
采用SPAIRE或标准外侧入路进行手术。术后3天和120天进行随访。
术后120天通过电话评估牛津髋关节评分（OHS）。次要结局指标：功能和活动能力（术后3天）、疼痛（术后3天、120天）、出院去向、住院时间、并发症和死亡率（120天内）、生活质量和居住地点（术后120天）。
参与者的平均年龄为84.6岁（标准差7.2）；168名（69%）为女性。主要结局：术后120天OHS差异的证据不足；调整后的平均差异（SPAIRE组-外侧入路组）为-1.23（95%置信区间为-3.96至1.49，p=0.37）。次要结局：SPAIRE组术后3天参与者报告的疼痛较低；其余结局在两组之间无差异。
无论是接受SPAIRE入路还是外侧入路，参与者在短期（3天）和长期（120天）的活动能力和功能相似。在住院时间、返回骨折前居住地点、120天内生存率或120天时的生活质量方面，两种入路均未显示出优于对方的优势。接受SPAIRE入路的参与者在术后早期可能疼痛较轻。在髋关节半关节置换术中将后入路改良为SPAIRE入路，在120天内患者结局与外侧入路相当。
NCT04095611。
