Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty

NCT02998034 | Completed

• 1 other identifier: 13/WM/0049
• Study Type: interventional
• Target: 400
• 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. There are a number of different designs of hemiarthroplasty that may be used. Some of the implants are fixed in place with bone cement whilst the rest are inserted as a press fit without the bone cement. The early designs of implant were all press fit but these designs have now been shown to be inferior to those implants that are fixed in place with bone cement. There are however a number of newer designs of implant that are coated with a substance (hydroxyapatite) that encourage the bone to grow onto the implant to fix it into place. To date these implants have only been compared to the cement fit implants in only one previous study. This study found no notable difference between the two types of hemiarthroplasty. This study aims to add to the research studies by comparing standard cement fit implant with a hydroxyapatite coated press fit implant to assist in determining the optimum surgical treatment for this common and disabling condition. Both implants to be used in this study are still being used extensively within the United Kingdom and worldwide to treat this fracture. The study is therefore using two different implants within their recommended area of use, but in which there is uncertainty as to which is the best implant.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• regain of mobility

  measurement with a mobility score - Kristensen MT, Bandholm T, Foss NB, Ekdahl C, Kehlet H. High inter-tester reliability of the new mobility score in patients with hip fracture. J Rehabil Med 2008;40:589-91.

  assessed at one year from injury

Study Arms (2)

Cemented monoblock hemiarthroplasty

EXPERIMENTAL

The cemented monoblock hemiarthroplasty is a double tapered polished stem with a hemiarthroplasty head cemented in place (Zimmer incorporated, UK)

Device: Cemented tapered stem hemiarthroplasty

Hyroxyapatite coated prosthesis

EXPERIMENTAL

the Furlong Hyroxyapatite coated prosthesis (JRI orthopaedics limited UK) is a hydroxyapatite coating uncemented a hip prosthesis with a hemiarthroplasty head. The implant is uncemented.

Device: Uncemented Furlong Hemiarthroplasty

Interventions

Uncemented Furlong Hemiarthroplasty DEVICE

A furlong uncemeneted hyroxyapatite coated prosthesis.The hydroxyapatite stimulates bone ingrowth around the prosthesis and is this is thought to reduce loosening of the implant, residual pain and the long-term revision rate.

Hyroxyapatite coated prosthesis

Cemented tapered stem hemiarthroplasty DEVICE

A cemented double tapered stem hemiarthroplasty

Cemented monoblock hemiarthroplasty

Eligibility Criteria

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

You may not qualify if:

• Younger patients in which internal fixation is felt to be the choice of treatment to preserve the femoral head. This is generally those aged less than 60 years in which these patient have an expected good long term survival and are all treated by reduction and internal fixation.
• All other patients in whom the injury is to be treated by reduction and internal fixation for a specific indication.
• Those patients who are able to walk independently out of doors with no more than the use of a stick and are not cognitively impaired. These patients will first be considered for the ongoing randomised trial of Hemiarthroplasty or Total hip replacement (R\&D reference - R\&D/2012/30, REC reference - 12/LO/15490)
• Patients who decline to participate.
• Patients admitted when MJP is not available to supervise treatment.

Sponsors & Collaborators

• Peterborough and Stamford Hospitals NHS Foundation Trust: lead

Study Sites (1)

Peterborough and Stamford Hospital NHS Foundation Trust

Peterborough, Cambs, PE36DA, United Kingdom

Location

Related Publications (1)

• Parker MJ, Cawley S. Cemented or uncemented hemiarthroplasty for displaced intracapsular fractures of the hip: a randomized trial of 400 patients. Bone Joint J. 2020 Jan;102-B(1):11-16. doi: 10.1302/0301-620X.102B1.BJJ-2019-1041.R1.

  PMID: 31888358 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

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)