Clinical effectiveness of a modified muscle sparing posterior technique compared to a standard lateral approach in hip hemiarthroplasty for displaced intracapsular fractures (HemiSPAIRE): a multicentre, parallel group, randomised controlled trial

Abstract

Objectives Assess 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 to a standard lateral approach. Design Pragmatic, superiority, multicentre, parallel-group, RCT (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 25 November 2019-25 April 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 pre-specified data collection window. Interventions Surgery using SPAIRE or standard lateral approach. Follow-up 3- and 120-days post-operation. Main outcome measure Oxford Hip Score (OHS), via telephone at 120 days. Secondary outcomes: function and mobility (3-days), pain (3-, 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- (3-days) and longer- (120-days) term, whether receiving the SPAIRE or lateral approach. Neither approach confers benefit over the other in terms of length of hospital stay, return to pre-fracture 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 ClinicalTrials.gov NCT04095611.