Title: The Hemi SPAIRE study: The effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthoplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach; A randomised controlled trial.
Funder: Department of Health and Social Care

Abstract: Research question: Does a modified, tendon-sparing technique used in a posterior approach for hip hemiarthroplasty confer benefits of improved function and mobility, compared to the standard lateral approach? Background: In the UK 20,000 patients a year sustain a hip fracture and require a hemiarthroplasty. Regaining function and mobility and maintaining independence are of paramount importance to elderly patients following this injury. The displaced intracapsular pattern is the most common type of hip fracture and is treated with cemented hemiarthroplasty. Health professionals should share any decision making with patients and make continued independent living and quality of life the priorities for treatment. Aims and objectives: To evaluate the effectiveness of the posterior approach using the SPAIRE technique (where the tendons of piriformis and obturator internus muscles are left intact) compared with the standard lateral approach for patients having hip hemiarthroplasty surgery. The primary outcome is level of function and mobility using the De Morton Mobility Index (DEMMI) test. Secondary outcomes are the Cumulated Ambulation Score (CAS), level of pain using the numeric pain rating scale (NPRS), health-related quality of life (EuroQol EQ-5D), the Oxford Hip Score, acute and total length of stay and specific hip-related complications such as dislocation. Qualitative work examining patient experience of the impact of surgery and recovery period will also be performed. Methods: This is a pragmatic multicentre randomised controlled trial recruiting eligible patients attending six acute hospitals in the south west of England with a displaced intracapsular fracture requiring hip hemiarthroplasty. Patients will be randomised in theatre to have their operation performed either by posterior approach using the SPAIRE technique or the standard lateral approach. Patients, ward staff and all research staff involved in post-operative evaluations will remain blinded to allocation. Outcomes will be recorded on the third post-operative day and at 120 days after surgery. On average 37 patients will be recruited by each of the six sites in the 20 month recruitment period, totalling 224 participants (112 per arm). Timelines for delivery: April to August 2019: Ethics and Governance approval, contracts and agreements, confirmation of principal investigators and surgeon collaborators in each site, training, initiation visits to all sites, recruitment of Trial Steering Committee and Data Monitoring Committee. September 2019 to April 2021: 20-month recruitment period including internal pilot for recruitment in first 6 months and qualitative work on recruitment from July to December 2020. August 2021: End of participant 120-day follow-up. September 2021 to January 2022: Analysis and report writing. January 2022: Study report complete. Anticipated impact and dissemination: Improved post-operative function could enable hip fracture patients to regain their previous level of mobility sooner, decreasing the risk of medical problems associated with prolonged recumbence and potentially reducing hospital stay. Such findings will encourage the adoption of a simple modification of a well-established surgical approach familiar to orthopaedic surgeons that could offer patients improved care at no increased cost. Dissemination will be provided by publications in scientific journals, presentations at National and International Meetings, use of social media networks and the scientific press.

Lay abstract: Which technique is best for partial hip replacement? Aim of the study: To compare two ways of performing partial hip replacement to see which one allows patients to mobilise more quickly and gives patients better function after surgery. The best approach is more likely to allow patients to maintain their independence and return to their own homes after their injury. Background: When someone breaks their hip they often need a partial hip replacement, also known as hemiarthroplasty. To perform this operation surgeons need to cut through some muscles to expose the hip joint and perform the partial replacement. Currently, clinical guidelines suggest that this operation should be performed using a technique which involves cutting muscles and tendons from the side of the hip. This is called the lateral approach. Alternatively, a newer, modified technique can be used leaving all the major muscles intact and this may cause fewer problems for the patient. There is no research evidence to prove which approach is more beneficial. Patients and carers looking for information about this are likely to become confused by the many opinions of surgeons speaking about preferred techniques. It is therefore important to find out which technique is better for patients, based on research rather than opinion. Study design: We will randomly allocate patients who agree to be part of the study to have one of the two techniques to partial hip replacement. We can then compare the impact of the two techniques on how quickly and fully patients mobilise, the level of pain they experience, and the safety of the techniques. We will also contact a number of patients from both treatment groups to discuss their experience of the surgery in more detail. Patient and public involvement: This study was inspired by patients who said that mobility and speed to regaining independence are the most important outcomes after surgery. Patients and carers will continue to be involved throughout this study, to ensure that the study results are relevant and important to people at risk of breaking their hip. Dissemination: We will publish the results of this study widely in scientific and other publications accessable to patients and all involved in the treatment of patients with hip fractures. We will work with surgeons, carers and patients to ensure all appropriate networks are aware of the results and that the outcomes are disseminated in an accessible way so that practices can be changed based on the results of this study.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS;MUSCULOSKELETAL