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Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Uncemented Furlong Hemiarthroplasty
Cemented tapered stem hemiarthroplasty
Sponsored by
Peterborough and Stamford Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients admitted to Peterborough City Hospital with a displaced intracapsular fracture will be considered for inclusion in the study.

Exclusion Criteria:

  • • 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.

Sites / Locations

  • Peterborough and Stamford Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cemented monoblock hemiarthroplasty

Hyroxyapatite coated prosthesis

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2016
Last Updated
March 9, 2021
Sponsor
Peterborough and Stamford Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02998034
Brief Title
Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty
Official Title
Randomised Controlled Trial of Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peterborough and Stamford Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
As a follow-on from our current randomised trials of different types of treatment for hip fractures, we wish to undertake a prospective randomised trial to compare a modern cemented hemiarthroplasty prosthesis with a modern hydroxyapatite coated uncemented arthroplasty. Cemented Exeter monoblock hemiarthroplasty The Exeter stemmed total hip replacement is considered one of foremost performing hip replacements in the world. The ETS (Exeter trauma stem) is one such implant and costs around £200. The implant has modern instrumentation and the stem has proven long term survival rates when used for total hip replacement. Hyroxyapatite coated prosthesis Coating a hip prosthesis with hydroxyapatite is common practice for an uncemented hip replacement arthroplasty. 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. The aim of the study is to assist in defining the optimum choice of arthroplasty for an acute hip fracture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cemented monoblock hemiarthroplasty
Arm Type
Experimental
Arm Description
The cemented monoblock hemiarthroplasty is a double tapered polished stem with a hemiarthroplasty head cemented in place (Zimmer incorporated, UK)
Arm Title
Hyroxyapatite coated prosthesis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Uncemented Furlong Hemiarthroplasty
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cemented tapered stem hemiarthroplasty
Intervention Description
A cemented double tapered stem hemiarthroplasty
Primary Outcome Measure Information:
Title
regain of mobility
Description
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.
Time Frame
assessed at one year from injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients admitted to Peterborough City Hospital with a displaced intracapsular fracture will be considered for inclusion in the study. Exclusion Criteria: • 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.
Facility Information:
Facility Name
Peterborough and Stamford Hospital NHS Foundation Trust
City
Peterborough
State/Province
Cambs
ZIP/Postal Code
PE36DA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no IPD will be generated
Citations:
PubMed Identifier
31888358
Citation
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.
Results Reference
background

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Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty

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