Clinical trial NCT04095611: A Modified Muscle Sparing Posterior Technique (SPAIRE) in Hip Hemiarthroplasty for Displaced Intracapsular Fractures.
Official title: The Effects of a Modified Muscle Sparing Posterior Technique (SPAIRE) in Hip Hemiarthroplasty for Displaced Intracapsular Fractures on Post-operative Function Compared to a Standard Lateral Approach; a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Keywords: Hemiarthroplasty
Hip fracture
Modified Muscle Sparing Posterior Technique (SPAIRE)
Displaced Intracapsular Hip Fracture
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Exeter
First posted: 2019-09-19
Enrollment: 244
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Which technique is best for partial hip replacement?

Detailed description: Aim of study: To compare two ways of performing partial hip replacement to see which one allows patients to mobilise better and gives patients improved 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 well 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.

Eligibility criteria: Inclusion Criteria:

- Patients aged 60+ presenting with an intracapsular hip fractures requiring cemented hip hemiarthroplasty (NICE CG124 2011), and who are resident in the South West of England

Exclusion Criteria:

* Patients that were immobile (unable to walk) before the hip fracture occurred.
* Patients that are not expected to live until post operative day 120 due to chronic illness and are receiving surgery for palliative care.
* Use of femoral stems that are not of a proven stem design, in line with the recommendations set by the NICE clinical guideline on hip fracture management (NICE CG124 2011).

Primary outcomes:
measure: Oxford Hip Score (OHS)
timeFrame: Post operative day 120
Secondary outcomes:
measure: De Morton Mobility Index (DEMMI)
timeFrame: Post operative day 3 and 120
measure: Cumulated Ambulation Score (CAS)
timeFrame: Post operative day 3
measure: Oxford Hip Score (OHS)
timeFrame: Post operative day 3
measure: Standardised instrument for measuring generic health status: European Quality of Life 5 Dimensions, 5 Levels (EQ-5D-5L)
timeFrame: Post operative day 3 and 120
measure: Numeric pain Rating Scale (NRS)
timeFrame: Post operative day 3 and 120
measure: Analgesia medications used by participants
timeFrame: Post operative day 3 and 120
measure: Adverse Events (AE) and Serious Adverse Events (SAE) will be recorded
timeFrame: Throughout study participation, on average 120 days
measure: Length of stay in hospital (acute and super-spell)
timeFrame: Recorded on day of discharge (likely day 4-10 post operation) and through study completion, on average 120 days
measure: Place of residence
timeFrame: At 3 time points (pre-fracture, on hospital discharge and at POD120). Throughout study participation, on average 120 days
measure: American Society of Anaesthesiologists (ASA) Physical Status Classification
timeFrame: Day of operation
measure: Qualitative interviews with participants
timeFrame: Post operative day 120
measure: Patient date of birth
timeFrame: Post operative day 3
measure: Patient gender
timeFrame: Post operative day 3
measure: Patient ethnicity
timeFrame: Post operative day 3
measure: Cognition as assessed by surgical team
timeFrame: Day of operation
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Trust
state: Devon
Study officials:
affiliation: Royal Devon and Exeter NHS Trust
name: John Charity, MD
role: STUDY_DIRECTOR
References:
citation: Price A, Ball S, Rhodes S, Wickins R, Gordon E, Aylward A, Cockcroft E, Morgan-Trimmer S, Powell R, Timperley J, Charity J. Effects of a modified muscle sparing posterior technique in hip hemiarthroplasty for displaced intracapsular fractures on postoperative function compared to a standard lateral approach (HemiSPAIRE): protocol for a randomised controlled trial. BMJ Open. 2021 Jun 8;11(6):e045652. doi: 10.1136/bmjopen-2020-045652.
citation: Ball S, McAndrew A, Aylward A, Cockcroft E, Gordon E, Kerridge A, Morgan-Trimmer S, Powell R, Price A, Rhodes S, Timperley AJ, van Horik J, Wickins R, Charity J. Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE. Trials. 2022 Nov 5;23(1):924. doi: 10.1186/s13063-022-06790-z.