A Modified Muscle Sparing Posterior Technique (SPAIRE) in Hip Hemiarthroplasty for Displaced Intracapsular Fractures.

NCT04095611 | Completed DMC

• 1 other identifier: IRAS: 258327
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

Which technique is best for partial hip replacement?

Conditions

Hip Fracture

Keywords

Hemiarthroplasty; Hip fracture; Modified Muscle Sparing Posterior Technique (SPAIRE); Displaced Intracapsular Hip Fracture

Outcome Measures

Primary Outcomes (1)

• Oxford Hip Score (OHS)

  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

  Post operative day 120

Secondary Outcomes (15)

• De Morton Mobility Index (DEMMI)

  Post operative day 3 and 120

• Cumulated Ambulation Score (CAS)

  Post operative day 3

• 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

Study Arms (2)

SPAIRE

EXPERIMENTAL

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

Procedure: SPAIRE

LATERAL

ACTIVE COMPARATOR

hemiarthroplasty surgery, the standard lateral approach

Procedure: LATERAL

Interventions

SPAIRE PROCEDURE

To perform the hip surgery called hemiarthroplasty surgeons need to cut through some muscles to expose the hip joint and perform the partial replacement. Currently this often performed using a technique which involves cutting muscles and tendons from the side of the hip and this is called the lateral approach. SPAIRE is a modified technique that accesses the surgical area through a different route.

SPAIRE

LATERAL PROCEDURE

surgery in adults with a displaced intracapsular hip fracture requiring hemiarthroplasty, the standard lateral approach.

LATERAL

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• University of Exeter: collaborator

Study Sites (1)

Royal Devon and Exeter NHS Trust

Exeter, Devon, EX25DW, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 34103316 BACKGROUND

• 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.

  PMID: 36335403 BACKGROUND

• Ball S, Aylward A, Cockcroft E, Corr A, Gordon E, Kerridge A, McAndrew A, Morgan-Trimmer S, Powell R, Price A, Rhodes S, Timperley AJ, van Horik J, Wickins R, Charity J. Clinical effectiveness of a modified muscle sparing posterior technique compared with a standard lateral approach in hip hemiarthroplasty for displaced intracapsular fractures (HemiSPAIRE): a multicenter, parallel-group, randomized controlled trial. BMJ Surg Interv Health Technol. 2024 Jun 17;6(1):e000251. doi: 10.1136/bmjsit-2023-000251. eCollection 2024.

  PMID: 38895600 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• John Charity, MD

  Royal Devon and Exeter NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The surgeon performing the operation will be aware which treatment the participant is receiving.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: September 19, 2019
• Study Start: November 25, 2019
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)