Hip FracturesNCT02998359
Hemiarthroplasty Versus Total Hip Replacement for Intracapsular Hip Fractures
A study testing Hemiarthroplasty and Total hip arthroplasty 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?
- Hemiarthroplasty and Total hip arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 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 District Hospital with a displaced intracapsular fracture will be considered for inclusion in the study. Patients will need to be
- 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
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Peterborough City Hospital
Peterborough, Cambridgeshire, PE3 9GZ
About this study
Official title: Randomised Controlled Trial of Hemiarthroplasty Versus Total Hip Replacement for Intracapsular Hip Fractures
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.
Read the detailed description
The trial will be run as close to the ideal trial methodology for a randomised trial as specified by the CONSORT statement as possible. This will include secure randomisation, intention to treat analysis, full reporting of outcomes and follow-up by a person who is blinded to the prosthesis used. The trial will follow the code of good clinical practice as specified by the hospital trusts Research and Development Committee.
In Peterborough all hip fracture patients are admitted to the acute trauma ward and transferred to the care of MJP. Those patients that are willing to participant in one of our randomised trials are consented prior to surgery. Treatment follows standard evidence based protocols with follow-up of all patients in a hip fracture clinic. A comprehensive database is maintained for all patients containing both audit and research data. Included in this is a standardised assessment of outcome.
The surgical treatments under comparison will be either a cemented Exeter stem monoblock prosthesis inserted via an anteriolateral surgical approach or a cemented Total hip replacement. The stem for the THR will be a polished tapered stem of the Exeter type with a 32 or 36mm head articulating with a cemented high density polyethylene cemented acetabular cup. All operations will be undertaken or supervised by MJP. Post-operative care programmes for the two patients will be identical.
After discharge patient will be seen once in the hip fracture clinic by MJP. At this time they will also be assessed by the research nurse who is blinded to the type of prosthesis used. The outcome questionnaire is completed which includes an assessment of hip movement and limb shortening. All subsequent follow-up assessments will be done by phone call from the research nurse. Any patient with significant residual symptoms will be asked to re-attend the hip fracture clinic.
- Conditions
- Hip Fractures
- Being tested
- Hemiarthroplasty, Total hip arthroplasty
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemiarthroplastyDevice
A cemented polished double taper stem hemiarthroplasty inserted via an anterior-lateral surgical approach (Zimmer incorporated, UK).
Total hip arthroplastyDevice
A cemented polished double taper stem arthroplasty stem inserted via an anterior-lateral surgical approach with a cemented acetabular cup (Zimmer incorporated, UK).
| Study group | Role | What they receive |
|---|---|---|
| Hemiarthroplasty | Active comparator | A cemented polished double taper stem hemiarthroplasty inserted via an anterior-lateral surgical approach (Zimmer incorporated, UK). Receives: 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). Receives: Device: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- 300 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
- NCT02998359
- Sponsor's protocol ID
- R&D/2012/30
- 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: not IPD anticipated
Publications
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.
PubMed 31543318
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 Hemiarthroplasty Versus Total Hip Replacement for Intracapsular Hip Fractures
- ClinicalTrials.gov ID
- NCT02998359
- Acronym / sponsor ID
- R&D/2012/30
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 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.
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.
Detailed description
The trial will be run as close to the ideal trial methodology for a randomised trial as specified by the CONSORT statement as possible. This will include secure randomisation, intention to treat analysis, full reporting of outcomes and follow-up by a person who is blinded to the prosthesis used. The trial will follow the code of good clinical practice as specified by the hospital trusts Research and Development Committee.
In Peterborough all hip fracture patients are admitted to the acute trauma ward and transferred to the care of MJP. Those patients that are willing to participant in one of our randomised trials are consented prior to surgery. Treatment follows standard evidence based protocols with follow-up of all patients in a hip fracture clinic. A comprehensive database is maintained for all patients containing both audit and research data. Included in this is a standardised assessment of outcome.
The surgical treatments under comparison will be either a cemented Exeter stem monoblock prosthesis inserted via an anteriolateral surgical approach or a cemented Total hip replacement. The stem for the THR will be a polished tapered stem of the Exeter type with a 32 or 36mm head articulating with a cemented high density polyethylene cemented acetabular cup. All operations will be undertaken or supervised by MJP. Post-operative care programmes for the two patients will be identical.
After discharge patient will be seen once in the hip fracture clinic by MJP. At this time they will also be assessed by the research nurse who is blinded to the type of prosthesis used. The outcome questionnaire is completed which includes an assessment of hip movement and limb shortening. All subsequent follow-up assessments will be done by phone call from the research nurse. Any patient with significant residual symptoms will be asked to re-attend the hip fracture clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemiarthroplasty | Active comparator | Device: HemiarthroplastyA cemented polished double taper stem hemiarthroplasty inserted via an anterior-lateral surgical approach (Zimmer incorporated, UK). |
| Total hip replacment | Active comparator | Device: Total hip arthroplastyA cemented polished double taper stem arthroplasty inserted via an anterior-lateral surgical approach with a cemented acetabular cup (Zimmer incorporated, UK). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All patients admitted to Peterborough District Hospital with a displaced intracapsular fracture will be considered for inclusion in the study. Patients will need to be
Key exclusion criteria (7 listed)
- • Those aged less than 50 years (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 |
|---|---|---|
| HemiarthroplastyA cemented polished double taper stem hemiarthroplasty inserted via an anterior-lateral surgical approach (Zimmer incorporated, UK). | Device | Hemiarthroplasty |
| Total hip arthroplastyA cemented polished double taper stem arthroplasty stem inserted via an anterior-lateral surgical approach with a cemented acetabular cup (Zimmer incorporated, UK). | Device | Total hip replacment |
Primary outcome
Change in a mobility score
Time frame: at one year from injury
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.
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.
- Results publication: PubMed 31543318Parker 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.
- Individual participant dataSharing planned: No. not IPD anticipated
Related trials for Hip Fractures
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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 Hemiarthroplasty and Total hip arthroplasty 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 4 inclusion and 7 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?
Change in a mobility score (time frame: 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 NCT02998359, 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.