Unipolar vs Bipolar Hemiarthroplasty for Hip Fracture

Prospective Randomised Controlled Trial of Unipolar vs Bipolar Hemiarthroplasty for Patients With an Intracapsular Hip Fracture

The purpose of this study is to determine whether significant functional benefits are seen in patients who have a bipolar hemiarthroplasty as treatment for hip fracture compared to those who have a unipolar hemiarthroplasty.

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Device: Unipolar hemiarthroplasty; Device: Bipolar hemiarthroplasty

Detailed Description

Proposed study design

Randomized controlled trial of unipolar vs bipolar hip hemiarthroplasty for intracapsular fracture of the femoral neck

The trial will be conducted in accordance with the GCP (Good Clinical Practice) guidelines and will be reported in line with the CONSORT statement

Study Centre

The Royal Infirmary of Edinburgh admits 1000 patients a year with a hip fracture; the largest number in any one centre in Scotland. Of these, 500 have intracapsular fractures, which is the type addressed in this study. Some patients will be better suited to a total hip replacement (5-10% of this group), and others may refuse to consent to the trial (previous experience has suggested a rate of 15-20%). Investigators therefore expect just over 300 patients to be recruitable each year, and so plan to allow up to two years for recruitment, and two years to complete follow up of the last patient

Brief Study Method

1. Patients will be identified as requiring a hemiarthroplasty for an intracapsular fracture of the femoral neck
2. Patients will be asked to consent to recruitment to study. Consent by attorney or nearest relative for patients with cognitive impairment
3. Surgery performed via anterolateral approach on standard trauma list. Standard cemented stem implanted.
4. Patient randomized in theatre to receive a unipolar or bipolar hemiarthroplasty head.
5. Tantalum beads will be implanted within the bone of the femur and pelvis (not the hip joint) by a consultant surgeon investigator when operating or assisting personally. These will not implanted where an unsupervised trainee is performing surgery. Fifty patients in each group will have these implants.
6. Patients undergo standard rehabilitation: physiotherapy, occupational therapy and geriatrician services as required.
7. Standard pre-op, post-op and one-year and two-year plain pelvic radiographs will be obtained.
8. Subset of patients: Fifty patients who have received a bipolar hemiarthroplasty will be asked to undergo one additional x-ray of the hip at two years to assess the function of the device.
9. Functional assessment: patients will undergo the Timed up-and-go (TUG) test, physiological measurements of hip muscle recruitment and function, and standardized questionnaires (SF12 and Harris Hip score).

Power analysis and number of patients

200 patients in each arm of study (total 400) allowing for expected 27% mortality at one year.

DMC (Data Monitoring Committee)

A data monitoring committee will review the results during the study period to allow the project to be terminated if statistical significance is reached or if there are any untoward events.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Lothian
    • Edinburgh, Lothian, United Kingdom, EH164SA
      • Royal Infirmary Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Patients admitted with an intracapsular fracture of the femoral neck who are suitable for a hemiarthroplasty.

Exclusion Criteria

• Patients deemed suitable for a total hip arthroplasty, patients with a high energy fracture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unipolar; Unipolar hemiarthroplasty used for treatment of intracapsular hip fracture	Device: Unipolar hemiarthroplasty; Other Names: C Stem AMT Unipolar Hemi Arthroplasty DePuy Synthes
Active Comparator: Bipolar; Bipolar hemiarthroplasty used for treatment of intracapsular hip fracture	Device: Bipolar hemiarthroplasty; Other Names: C Stem AMT Bipolar Hemi Arthroplasty DePuy Synthes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	visual analogue scale pain score ( on a 10cm baseline fro 'no pain' to 'worst pain imaginable'	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	visual analogue scale pain score ( on a 10cm baseline fro 'no pain' to 'worst pain imaginable'	2 years
Function	as assessed by 'timed up and go test',	1 year
Radiographic assessment	year evidence of acetabular erosion measured with radiostereometric assessment (RSA)	1 year
Complications	duration of surgery (minutes)	intraoperative
Function	physical examination of range of motion	1 year
Function	physical examination of range of motion	2 years
Function and self care	Barthel Index	1 year
Function and self care	Barthel Index	2 years
Function and general health	Short form 12	1 year
Function and general health	Short form 12	2 years
Function	Harris Hip Score	1 year
Function	Harris Hip Score	2 years
Complications	presence of surgical site infection	up to 2 years
complications	Deep venous thorombosis	up to 2 years
complication	Periprosthetic fracture	up to 2 years
Complication	prosthesis dislocation	up to 2 years
Complication	implant failure	up to 2 years
complication	repoeration any cause	up to 2 years
Complication	death	up to 2 years
Function	as assessed by 'timed up and go test',	2 years

Collaborators and Investigators

• Sponsor: NHS Lothian
• Investigators: Principal Investigator: Leela Biant, MD, MBBS, NHS Lothian

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2014
• Primary Completion (Actual): June 26, 2019
• Study Completion (Actual): June 26, 2019

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Estimated): November 14, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: REC: 13/SS/0186 IRAS139897