■评估改良的保留肌肉后入路的效果;SPEIRE(保存梨状肌和内内肌,修复Externus),与标准外侧入路相比,半髋关节置换术治疗移位的囊内骨折对术后活动度和功能的影响。
■务实,优越性,多中心,平行组,随机对照试验(内部试点)。参与者,病房工作人员,进行术后评估的研究人员对分配不知情.CTU使用计算机生成的列表集中分配治疗。
■英格兰西南部的六家医院,招聘2019年11月25日-2022年4月25日。
■244名需要髋关节置换术的成年人(≥60岁)(每种入路分配122名)。分配给SPAIRE和横向的90名和85名参与者,分别,在预设的数据收集窗口内有主要结局数据.
■使用SPAIRE或标准外侧入路进行手术。术后3天和120天随访。
■牛津髋关节评分(OHS),通过电话在120天。次要结果:功能和流动性(3天),疼痛(3天,120天),排放目的地,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(SD7.2);168名(69%)为女性。主要结果:120天时OHS差异的证据很少;调整后的平均差异(SPAIRE-侧向)-1.23(95%CI-3.96至1.49,p=0.37)。次要结果:在SPAIRE组3天时,参与者报告的疼痛程度较低;其余结果在两组之间没有差异。
■参与者\'的流动性和功能在短期(3天)和长期(120天)方面相似,无论是接收SPAIRE还是横向进近。在住院时间方面,这两种方法都不能比另一种方法受益。返回骨折前住所,在120天内存活,或120天的生活质量。接受SPAIRE方法的参与者在术后早期可能会经历较少的疼痛。在120天内,将髋关节置换术中的后入路修改为SPAIRE入路可使患者的预后与外侧入路相同。
■NCT04095611。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Six hospitals in Southwest England, recruiting November 25, 2019-April 25, 2022.
UNASSIGNED: 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.
UNASSIGNED: Surgery using SPAIRE or standard lateral approach. Follow-up 3 days and 120 days postoperation.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: NCT04095611.