Hemiarthroplasty Versus Total Hip Replacement for Intracapsular Hip Fractures

NCT02998359 | Completed

• 1 other identifier: R&D/2012/30
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In England each year over 9,000 people fracture their hip. Most of these are elderly females with the fracture occurring after a fall. Approximately half of these fractures are classified as intracapsular fractures because of their close proximity to the hip joint. The majority of these fractures are treated surgically by excising the broken femoral neck and removing the femoral head (ball part of the hip joint) and replacing it with an artificial hip joint. This hip replacement has traditionally been a hemiarthroplasty or sometimes termed a 'half hip replacement' in which only the ball part of the hip joint is replaced. An alternative type of hip replacement is the full total hip replacement in which the socket part of the joint is also replaced. This is the operation that is used for replacing arthritic hips. In recent years there have been a number of randomised trials that have compared the outcome for patients with an intracapsular hip fracture treated with either a partial hip replacement (hemiarthroplasty) against those treated with a total hip replacement (THR). Results to date have suggested slightly better long term functional results for those treated with a THR, but it still remains unclear if these benefits are offset by the increased surgical complexity of the procedure and the extra cost involved for a THR. At present the numbers of studies on this topic are too few with limited patient numbers to make any definite conclusions. This study aims to add to the research studies by comparing the two surgical procedures, to enable orthopaedic surgeons to determine the optimum surgical treatment for this common and disabling condition.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Change in a mobility score

  A nine point mobility score - Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg 1993;75-B:797-8.

  at one year from injury

Study Arms (2)

Hemiarthroplasty

ACTIVE COMPARATOR

A cemented polished double taper stem hemiarthroplasty inserted via an anterior-lateral surgical approach (Zimmer incorporated, UK).

Device: Hemiarthroplasty

Total hip replacment

ACTIVE COMPARATOR

A cemented polished double taper stem arthroplasty inserted via an anterior-lateral surgical approach with a cemented acetabular cup (Zimmer incorporated, UK).

Device: Total hip arthroplasty

Interventions

Hemiarthroplasty DEVICE

A cemented polished double taper stem hemiarthroplasty inserted via an anterior-lateral surgical approach (Zimmer incorporated, UK).

Hemiarthroplasty

Total hip arthroplasty DEVICE

A cemented polished double taper stem arthroplasty stem inserted via an anterior-lateral surgical approach with a cemented acetabular cup (Zimmer incorporated, UK).

Total hip replacment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• able to walk independently out of doors with no more than the use of a stick
• not cognitively impaired
• medically fit for anaesthesia for either procedure

You may not qualify if:

• Those aged less than 50 years (these patient have an expected good long term survival and are all treated by reduction and internal fixation).
• All other patients in which the injury is to be treated by reduction and internal fixation.
• Those with impaired mobility prior to the injury (defined as not able to walk out of doors with no more than the use of a stick).
• Patients who are not considered to be medically fit for either procedure.
• Patients who decline to participate.
• Patients with senile dementia and those without the capacity to give informed consent. These patients are defined as those with a standard mental test score of lower than 5 our of 10. (These patients from previous studies have been found to be at increased risk of dislocation and post-operative complications after THR and this method of treatment is not recommended for this group).
• Patients admitted when MJP is not available to supervise treatment.

Sponsors & Collaborators

• Peterborough and Stamford Hospitals NHS Foundation Trust: lead

Study Sites (1)

Peterborough City Hospital

Peterborough, Cambridgeshire, PE3 9GZ, United Kingdom

Location

Related Publications (1)

• Parker MJ, Cawley S. Treatment of the displaced intracapsular fracture for the 'fitter' elderly patients: A randomised trial of total hip arthroplasty versus hemiarthroplasty for 105 patients. Injury. 2019 Nov;50(11):2009-2013. doi: 10.1016/j.injury.2019.09.018. Epub 2019 Sep 10.

  PMID: 31543318 RESULT

MeSH Terms

Conditions

Hip Fractures

Interventions

Hemiarthroplasty; Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant orthopaedic surgeon

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: August 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2019
• Last Updated: March 11, 2021

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)