Hip FracturesNCT04372966
Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures
A study testing Total hip arthroplasty in people with Hip Fractures, run by NHS Lothian at 1 site in United Kingdom.
Trial summary
Displaced subcapital hip fractures are very common and account for almost 50% of all hip fractures. The aim of the present study is to determine whether an uncemented total hip replacement is better than conventional cemented hip replacement to treat these fractures. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Sep 2009to 29 Dec 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over the age of 60 years with a displaced intracapsular hip fracture and are admitted to the study centre and are under the care of four orthopaedic trauma surgeons
- patients who were independently mobile before their hip fracture
- patients without cognitive impairment (mini-mental score >6) and able to give informed consent
- patients without serious concomitant disease
Who cannot join
- those not meeting the inclusion criteria
- patients who are not independently mobile outside the home
- unable to give informed consent
- serious concomitant disease with anaesthetic risk too great for Tsurgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Double Blind Randomised Controlled Trial Comparing the Uncemented (CORAIL, DePuy) Versus Cemented (Exeter) Total Knee Arthroplasty for Displaced Subcapital Hip Fractures
Displaced subcapital hip fractures are very common and account for almost 50% of all hip fractures. The aim of the present study is to determine whether an uncemented total hip replacement is better than conventional cemented hip replacement to treat these fractures.
Read the detailed description
Hip fractures account for 20% of all fractures and displaced subcapital fractures represent 45% of the hip fracture workload. All of these patients are treated with some form of hip replacement. Recent randomised trials have confirmed that total hip replacement is probably the best choice of treatment in a fit older patient and is better than partial hip replacement or repair of the fracture with screws which are the other most commonly used treatments. Hip replacements may be cemented or uncemented. The uncemented type of hip replacement has not been commonly used in this group of patients but may have some advantages. The uncemented hip replacement is a shorter operation and this may be advantageous in the hip fracture population group since these are older patients, many of whom have other medical problems. The use of cement is occasionally associated with development of heart problems during anaesthesia.
Participants: The original aim was to recruit 200 patients who have been admitted with a displaced subcapital hip fracture to the New Royal Infirmary and will undergo total hip replacement surgery within 48 hours of admission. Patients fitting the inclusion criteria will be given a patient information sheet and will be given between 24-48 hours to decide whether they give consent to participate in the trial. Patients who have given their consent will be randomly allocated to one of two groups i.e.. allocation to one of the two groups will entirely by chance. Each group will have 100 patients.
Intervention Both groups will received a total hip replacement. The only difference between the two groups is the type of hip replacement and the way it is fixed in the thigh bone. One type of hip replacement requires cement ('Exeter'), the other ('CORAIL' from DePuy) doesn't. Other surgical protocols and care after the surgery will be exactly the same for both groups.
Purpose The purpose of this research is to compare the clinical outcome (i.e. complications, revisions etc.) and the function of the patients between the two groups at several different time points: around 8 weeks, 4 months, 12 months and 24 months post surgery.
Outcome measures Clinical: Surgery complications, duration of surgery, readmissions, revision surgery, duration of hospital stay.
- Conditions
- Hip Fractures
- Being tested
- 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.
Total hip arthroplastyDevice
Also called Total hip replacement
Corail Total hip arthroplasty system, Depuy. Exeter and Contemporary acetabular components, Stryker.
| Study group | Role | What they receive |
|---|---|---|
| Cemented | Active comparator | This group will receive a cemented Exeter stem and contemporary acetabular component (Stryker). Receives: Device: Total hip arthroplasty |
| Uncemented | Active comparator | This group will receive an uncemented Corail stem and uncemented acetabular component (Depuy). Receives: Device: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip specific function
This was measured using the Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.
Measured: 1 year
Secondary outcomes (10)
Hip specific function
Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.
Measured: 6 and 72 months
Hip specific function
Harris Hip Score which ranges from 0 (worst score) to 100 (best score) points.
Measured: 6, 12 and 72 months
Generic health
Euro Qol 5-dimension scale (3L) which ranges from -0.594 to 1, where 1 represents perfect health and 0 represents death. Negative values represent a state perceived as worse than death.
Measured: 6, 12 and 72 months
Mobility
Timed get up and go test
Measured: 6 months
Subjective patient hip pain
Pain visual analogue scale from 1 (no pain) to 10 (maximum pain)
Measured: 6, 12 and 72 months
Operative time
Time from knife to skin to wound closure
Measured: At time of index surgery
Intraoperative blood loss
Amount of blood lost during the index proceedure
Measured: At time of of surgery
Patient satisfaction
Overall how satisfied are you with the results of your hip replacement surgery?" The response to each question was recorded using a five-point Likert scale: very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, and very dissatisfied.
Measured: 6, 12 and 72 months
Complications
Rate of complications (intra / post operative)
Measured: Time of surgery until one year following surgery
Survival
Kaplan Meier assessment of implant survival
Measured: Time of index surgery until final follow up (72 months), revision or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start24 Sep 2009
- Primary completion29 Dec 2011
- Study completion29 Dec 2016
Why it stopped: The Chief Investigator (John Keating)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Randomaised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372966
- Sponsor's protocol ID
- 06/S0501/80
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not planned
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double Blind Randomised Controlled Trial Comparing the Uncemented (CORAIL, DePuy) Versus Cemented (Exeter) Total Knee Arthroplasty for Displaced Subcapital Hip Fractures
- ClinicalTrials.gov ID
- NCT04372966
- Acronym / sponsor ID
- 06/S0501/80
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Chief Investigator (John Keating)
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- 24 Sep 2009 (actual)
- Primary completion
- 29 Dec 2011 (actual)
- Study completion
- 29 Dec 2016 (actual)
- First posted
- 4 May 2020 (actual)
- 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.
Displaced subcapital hip fractures are very common and account for almost 50% of all hip fractures. The aim of the present study is to determine whether an uncemented total hip replacement is better than conventional cemented hip replacement to treat these fractures.
Detailed description
Hip fractures account for 20% of all fractures and displaced subcapital fractures represent 45% of the hip fracture workload. All of these patients are treated with some form of hip replacement. Recent randomised trials have confirmed that total hip replacement is probably the best choice of treatment in a fit older patient and is better than partial hip replacement or repair of the fracture with screws which are the other most commonly used treatments. Hip replacements may be cemented or uncemented. The uncemented type of hip replacement has not been commonly used in this group of patients but may have some advantages. The uncemented hip replacement is a shorter operation and this may be advantageous in the hip fracture population group since these are older patients, many of whom have other medical problems. The use of cement is occasionally associated with development of heart problems during anaesthesia.
Participants: The original aim was to recruit 200 patients who have been admitted with a displaced subcapital hip fracture to the New Royal Infirmary and will undergo total hip replacement surgery within 48 hours of admission. Patients fitting the inclusion criteria will be given a patient information sheet and will be given between 24-48 hours to decide whether they give consent to participate in the trial. Patients who have given their consent will be randomly allocated to one of two groups i.e.. allocation to one of the two groups will entirely by chance. Each group will have 100 patients.
Intervention Both groups will received a total hip replacement. The only difference between the two groups is the type of hip replacement and the way it is fixed in the thigh bone. One type of hip replacement requires cement ('Exeter'), the other ('CORAIL' from DePuy) doesn't. Other surgical protocols and care after the surgery will be exactly the same for both groups.
Purpose The purpose of this research is to compare the clinical outcome (i.e. complications, revisions etc.) and the function of the patients between the two groups at several different time points: around 8 weeks, 4 months, 12 months and 24 months post surgery.
Outcome measures Clinical: Surgery complications, duration of surgery, readmissions, revision surgery, duration of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomaised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cemented | Active comparator | Device: Total hip arthroplastyThis group will receive a cemented Exeter stem and contemporary acetabular component (Stryker). |
| Uncemented | Active comparator | Device: Total hip arthroplastyThis group will receive an uncemented Corail stem and uncemented acetabular component (Depuy). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients over the age of 60 years with a displaced intracapsular hip fracture and are admitted to the study centre and are under the care of four orthopaedic trauma surgeons
- patients who were independently mobile before their hip fracture
- patients without cognitive impairment (mini-mental score >6) and able to give informed consent
- patients without serious concomitant disease
Key exclusion criteria (4 listed)
- those not meeting the inclusion criteria
- patients who are not independently mobile outside the home
- unable to give informed consent
- serious concomitant disease with anaesthetic risk too great for Tsurgery
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 |
|---|---|---|
| Total hip arthroplastyAlso: Total hip replacementCorail Total hip arthroplasty system, Depuy. Exeter and Contemporary acetabular components, Stryker. | Device | Cemented, Uncemented |
Primary outcome
Hip specific function
Time frame: 1 year
This was measured using the Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.
10 secondary outcomes
Hip specific function
Time frame: 6 and 72 months
Hip specific function
Time frame: 6, 12 and 72 months
Generic health
Time frame: 6, 12 and 72 months
Mobility
Time frame: 6 months
Subjective patient hip pain
Time frame: 6, 12 and 72 months
Operative time
Time frame: At time of index surgery
Intraoperative blood loss
Time frame: At time of of surgery
Patient satisfaction
Time frame: 6, 12 and 72 months
Complications
Time frame: Time of surgery until one year following surgery
Survival
Time frame: Time of index surgery until final follow up (72 months), revision or death
Results and safety
The study was stopped early (reason given: The Chief Investigator (John Keating)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Individual participant dataSharing planned: No. This is not planned
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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 Total hip arthroplasty in people with Hip Fractures, run by NHS Lothian 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 4 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: stopped early, as of the sponsor's last update on 4 May 2020. 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 was stopped early (reason given: The Chief Investigator (John Keating)). Results are not available in the source record.
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?
Hip specific function (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2020.