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Clinical Trials/NCT04095611
NCT04095611CompletedNot Applicable

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

Royal Devon and Exeter NHS Foundation Trust1 site in 1 country244 target enrollmentStarted: November 25, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
244
Locations
1
Primary Endpoint
Oxford Hip Score (OHS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

The surgeon performing the operation will be aware which treatment the participant is receiving.

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Arms & Interventions

SPAIRE

Experimental

hemiarthroplasty surgery, the muscle-sparing modification of the posterior approach (SPAIRE).

Intervention: SPAIRE (Procedure)

LATERAL

Active Comparator

hemiarthroplasty surgery, the standard lateral approach

Intervention: LATERAL (Procedure)

Outcomes

Primary Outcomes

Oxford Hip Score (OHS)

Time Frame: Post operative day 120

The Oxford Hip Score is a short patient-reported measure of function and pain following hip surgery (Dawson 1996). OHS Range: 0-48, with higher scores representing a better outcome

Secondary Outcomes

  • Oxford Hip Score (OHS)(Post operative day 3)
  • Standardised instrument for measuring generic health status: European Quality of Life 5 Dimensions, 5 Levels (EQ-5D-5L)(Post operative day 3 and 120)
  • Numeric pain Rating Scale (NRS)(Post operative day 3 and 120)
  • Cumulated Ambulation Score (CAS)(Post operative day 3)
  • Length of stay in hospital (acute and super-spell)(Recorded on day of discharge (likely day 4-10 post operation) and through study completion, on average 120 days)
  • Qualitative interviews with participants(Post operative day 120)
  • De Morton Mobility Index (DEMMI)(Post operative day 3 and 120)
  • Adverse Events (AE) and Serious Adverse Events (SAE) will be recorded(Throughout study participation, on average 120 days)
  • Patient gender(Post operative day 3)
  • Analgesia medications used by participants(Post operative day 3 and 120)
  • Place of residence(At 3 time points (pre-fracture, on hospital discharge and at POD120). Throughout study participation, on average 120 days)
  • American Society of Anaesthesiologists (ASA) Physical Status Classification(Day of operation)
  • Patient date of birth(Post operative day 3)
  • Patient ethnicity(Post operative day 3)
  • Cognition as assessed by surgical team(Day of operation)

Investigators

Sponsor
Royal Devon and Exeter NHS Foundation Trust
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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