Hip FracturesNCT02998034
Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty
A study testing Uncemented Furlong Hemiarthroplasty and Cemented tapered stem hemiarthroplasty in people with Hip Fractures, run by Peterborough and Stamford Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Uncemented Furlong Hemiarthroplasty and Cemented tapered stem hemiarthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to Peterborough City Hospital with a displaced intracapsular fracture will be considered for inclusion in the study.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Peterborough and Stamford Hospital NHS Foundation Trust
Peterborough, Cambs, PE36DA
About this study
Official title: Randomised Controlled Trial of Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty
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.
Read more
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.
Read the 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.
- Conditions
- Hip Fractures
- Being tested
- Uncemented Furlong Hemiarthroplasty, Cemented tapered stem hemiarthroplasty
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncemented Furlong HemiarthroplastyDevice
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.
Cemented tapered stem hemiarthroplastyDevice
A cemented double tapered stem hemiarthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Cemented monoblock hemiarthroplasty | Experimental | The cemented monoblock hemiarthroplasty is a double tapered polished stem with a hemiarthroplasty head cemented in place (Zimmer incorporated, UK) Receives: 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. Receives: Device: Uncemented Furlong Hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assessed at one year from injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startAug 2013
- Primary completionJun 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peterborough and Stamford Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martyn J Parker, Peterborough and Stamford Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998034
- Sponsor's protocol ID
- 13/WM/0049
- Status last verified
- Apr 2018
- First submitted
- 16 Dec 2016
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no IPD will be generated
Publications
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.
PubMed 31888358
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty
- ClinicalTrials.gov ID
- NCT02998034
- Acronym / sponsor ID
- 13/WM/0049
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Peterborough and Stamford Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented monoblock hemiarthroplasty | Experimental | Device: Cemented tapered stem hemiarthroplastyThe cemented monoblock hemiarthroplasty is a double tapered polished stem with a hemiarthroplasty head cemented in place (Zimmer incorporated, UK) |
| Hyroxyapatite coated prosthesis | Experimental | Device: Uncemented Furlong Hemiarthroplastythe Furlong Hyroxyapatite coated prosthesis (JRI orthopaedics limited UK) is a hydroxyapatite coating uncemented a hip prosthesis with a hemiarthroplasty head. The implant is uncemented. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to Peterborough City Hospital with a displaced intracapsular fracture will be considered for inclusion in the study.
Key exclusion criteria (5 listed)
- • 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uncemented Furlong HemiarthroplastyA 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. | Device | Hyroxyapatite coated prosthesis |
| Cemented tapered stem hemiarthroplastyA cemented double tapered stem hemiarthroplasty | Device | Cemented monoblock hemiarthroplasty |
Primary outcome
regain of mobility
Time frame: assessed at one year from injury
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Background: PubMed 31888358Parker 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.
- Individual participant dataSharing planned: No. no IPD will be generated
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uncemented Furlong Hemiarthroplasty and Cemented tapered stem hemiarthroplasty in people with Hip Fractures, run by Peterborough and Stamford Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regain of mobility (time frame: assessed at one year from injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02998034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.