Femoral Neck FracturesNCT01578408
Cemented Versus Uncemented Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures
A study testing Total Hip Arthroplasty and Uncemented HA Coated Corail stem in people with Femoral Neck Fractures, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this prospective randomized study is to compare the quality of treatment between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Total Hip Arthroplasty and Uncemented HA Coated Corail stem
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSweden
- Study dates
- 11 May 2010to 19 Feb 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are acutely admitted to hospital with dislocated femoral neck fractures, that in clinical praxis are in the need of hip prosthesis surgery, are recruited in the study. The fracture shall not engage the lesser nor the greater trochanters.
- Patients who wants to participate in the study and who can consider participation for at least 1 year.
- Coming from independent dwelling conditions.
- Not dementia.
- Circa 60-85 years of age.
- Circa 50 patients in each arm/group shall be included at Mölndal's Hospital (part of Sahlgrenska University Hospital).
Who cannot join
- Patients who have difficulties in understanding the intent of the study.
- Rheumatic disorders (RA, Bechterew, SLE).
- Cortison treatment.
- Stroke with remaining weakness or neurological disorders with affection of locomotion.
- Dementia.
- Grave obesity with BMI >=30-35.
- Delay between time of injury and time of surgery exceeding 72 hours.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Mölndals Hospital (part of Sahlgrenska University Hospital)
Mölndal, 43180
About this study
Official title: Corail-SP Study - A Prospective Randomized Comparison Between Cemented and Uncemented Hydroxyapatite Coated Prosthesis Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures
The purpose of this prospective randomized study is to compare the quality of treatment between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures.
Our hypothesis is that an uncemented option spares the patient the operative load of the cementing procedure, i e risk of fatty embolism and inflammatory response, which in turn also perhaps reduces the postoperative cognition strain and improves mobilization parameters.
If the uncemented option has the same excellent fixation in poor bone stock, as in the case of these osteopenic fractures, and also has the same good clinical outcome, it would be a viable standard option for the treatment of dislocated femoral neck fractures.
Read the detailed description
Corail-SP study. A prospective randomized study to compare the quality of treatment between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures.
Femoral neck fractures often occurs among the fragile elderly patients who have a higher degree of co-morbidity. The 3-month mortality is 13%. The incidence of risk of fracture complications when using osteosyntheses are as high as 30-40%, mainly due to non union, which leads to impairments in quality of life, locomotion and pain.
For that reason more patients nowadays are submitted to a cemented hemiarthroplasty or a total hip arthroplasty directly after their injury - at the same time the problem with fatty embolism syndrome has been recognized. When cementing during surgery, the bone marrow is pushed into the blood stream, which can affect the cardiopulmonary function and even the mental functions.
As a measure for reducing those risks an uncemented hip arthroplasty is sometimes used instead.
The pros and cons with uncemented fixation is poorly examined which this study will try to scrutinize.
100 patients with dislocated (Garden classification III-IV) femoral neck fractures who have the clinical indication of undergoing a Total Hip Arthroplasty are asked and included at Mölndals Hospital (part of Sahlgrenska University Hospital).
Randomization to either; an inversed hybrid arthroplasty with an uncemented hydroxyapatite coated Corail stem and a cemented Marathon cup (DePuy), alternatively to, a totally cemented option with a Lubinus SPII stem and a IP cup (Link).
Preoperatively:
Patient questionnaires regarding cognitive and social status, hip function, quality of life (QoL), activity level. Standard hip and pelvis X-ray. Blood sample for biomarkers.
Peroperatively:
Pulmonary artery catheter measurements of pulmonary artery pressure, cardiac output, ejection fraction of the right ventricle. Surgeon's questionnaire regarding prosthesis components, duration of surgery, blood group, bleeding volume, oxygen saturation. Half of the patients are marked with tantalum pellets for radiostereometric analysis (RSA). Biomarkers.
Postoperatively:
Standard X-ray. On the patients marked with tantalum pellets RSA is performed. Bone density scan (DXA). Measurements regarding cognition, ADL, mobilization. Eventual confusion is noted. Biomarkers every second day until discharge from hospital. Eventual wound infections or thromboembolic episodes are noted.
Follow up:
Outpatient return visits to physician 3, 6 months, 1, 2, 5, 7, 10 years postoperatively. Standard X-ray, RSA, DXA, Patient questionnaires regarding patient's satisfaction, QoL, activity level, hip function. Biomarkers.
Eventual gains with an uncemented prosthesis:
Reduced fatty embolism risk, reduced inflammatory response, reduced generalized symptoms/confusion, faster mobilization, shorter surgery.
- Conditions
- Femoral Neck Fractures
- Being tested
- Total Hip Arthroplasty, Cemented Lubinus SPII stem (control arm), Uncemented HA Coated Corail stem
- Keywords
- Femoral neck fractures, Uncemented, Hydroxyapatite, Coated, Femoral, Stems, Hip fractures, THA, THR, Cemented, Fat embolism, Cognition, Inflammatory response, Mobilization
- Medical subject headings
- Femoral Neck Fractures, Hip Fractures, Embolism, Fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Cemented Lubinus SPII stem (control arm)Device
Cemented Lubinus femoral stem. Cemented IP acetabular cup. (Link).
Uncemented HA Coated Corail stemDevice
Uncemented hydroxyapatite coated Corail femoral stem. Cemented Marathon acetabular cup. (DePuy).
| Study group | Role | What they receive |
|---|---|---|
| Uncemented HA Coated Corail stem | Active comparator | Surgery with an inversed hybrid arthroplasty with an uncemented hydroxyapatite coated Corail stem and a cemented Marathon cup (DePuy). Receives: Procedure: Total Hip Arthroplasty; Device: Uncemented HA Coated Corail stem |
| Cemented Lubinus SPII stem (control arm) | Active comparator | Surgery with a totally cemented option with a Lubinus SPII stem and a IP cup (Link). Receives: Procedure: Total Hip Arthroplasty; Device: Cemented Lubinus SPII stem (control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to mobilization.
Time (days) to mobilization defined as independent walking with or without walking aids measured by ward physiotherapist with Traffic Light System and Sahlgrenska University Hospital Hip Score (SUHS).
Measured: During hospital stay, an expected average of 10 days.
Secondary outcomes (7)
Cognitive status. Eventual confusion.
Cognitive status measured once daily with Pfeiffer's test (Short Portable Mental Status Questionnaire - SPMSQ).
Eventual confusion is noted once daily.
Measured: During hospital stay, an expected average of 10 days.
Oxygen saturation levels peroperatively.
POX-measurements during different phases of surgery along with pulmonary catheter readings.
Measured: Peroperatively (during surgery), an expected average of 2 hours.
Bone remodeling around the hip prosthesis.
Measurements with hip DXA.
Measured: Postoperatively in average after 2 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.
Biomarkers / inflammatory response.
Blood samples for measurement of the inflammatory response with biochip multi-array technology.
Measured: Preoperatively in average 4 hours. Peroperatively at end of wound closure. Postoperatively 1, 3, 5, 7 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.
Fixation / migration / loosening of the hip prosthesis components.
Measured by radiostereometric analysis (RSA) in addition to the conventional pelvis and hip X-ray exams. Early radiological loosening of one or both of the prosthesis components is identified at an early stage with RSA.
Measured: Postoperatively in average after 2 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.
Reoperation.
In case of for example infection or dislocation.
Measured: Postoperatively up to 10 years.
PROM - Patient Reported Outcome Measurements.
Questionnaires regarding Patient's satisfaction, Quality of life (EQ-5D), Activity level (UCLA), Harris Hip Score.
Measured: Preoperatively in average 4 hours. Postoperatively at discharge from hospital at an expected average of 10 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study start11 May 2010
- Primary completion9 Mar 2018
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Principal investigator, Arun Patel, MD, Sahlgrenska University Hospital
- Investigators
- Johan Kärrholm, Prof MD PhD, Study director, Orthopaedic Department, Sahlgrenska University Hospital, Gothenburg, SWEDEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578408
- Sponsor's protocol ID
- Corail-SP Study
- Status last verified
- Sep 2020
- First submitted
- 11 Apr 2012
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corail-SP Study - A Prospective Randomized Comparison Between Cemented and Uncemented Hydroxyapatite Coated Prosthesis Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT01578408
- Acronym / sponsor ID
- Corail-SP Study
- Conditions
- Femoral Neck Fractures
- Keywords
- Femoral neck fractures, Uncemented, Hydroxyapatite, Coated, Femoral, Stems, Hip fractures, THA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- 11 May 2010 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 17 Apr 2012 (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.
The purpose of this prospective randomized study is to compare the quality of treatment between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures.
Our hypothesis is that an uncemented option spares the patient the operative load of the cementing procedure, i e risk of fatty embolism and inflammatory response, which in turn also perhaps reduces the postoperative cognition strain and improves mobilization parameters.
If the uncemented option has the same excellent fixation in poor bone stock, as in the case of these osteopenic fractures, and also has the same good clinical outcome, it would be a viable standard option for the treatment of dislocated femoral neck fractures.
Detailed description
Corail-SP study. A prospective randomized study to compare the quality of treatment between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures.
Femoral neck fractures often occurs among the fragile elderly patients who have a higher degree of co-morbidity. The 3-month mortality is 13%. The incidence of risk of fracture complications when using osteosyntheses are as high as 30-40%, mainly due to non union, which leads to impairments in quality of life, locomotion and pain.
For that reason more patients nowadays are submitted to a cemented hemiarthroplasty or a total hip arthroplasty directly after their injury - at the same time the problem with fatty embolism syndrome has been recognized. When cementing during surgery, the bone marrow is pushed into the blood stream, which can affect the cardiopulmonary function and even the mental functions.
As a measure for reducing those risks an uncemented hip arthroplasty is sometimes used instead.
The pros and cons with uncemented fixation is poorly examined which this study will try to scrutinize.
100 patients with dislocated (Garden classification III-IV) femoral neck fractures who have the clinical indication of undergoing a Total Hip Arthroplasty are asked and included at Mölndals Hospital (part of Sahlgrenska University Hospital).
Randomization to either; an inversed hybrid arthroplasty with an uncemented hydroxyapatite coated Corail stem and a cemented Marathon cup (DePuy), alternatively to, a totally cemented option with a Lubinus SPII stem and a IP cup (Link).
Preoperatively:
Patient questionnaires regarding cognitive and social status, hip function, quality of life (QoL), activity level. Standard hip and pelvis X-ray. Blood sample for biomarkers.
Peroperatively:
Pulmonary artery catheter measurements of pulmonary artery pressure, cardiac output, ejection fraction of the right ventricle. Surgeon's questionnaire regarding prosthesis components, duration of surgery, blood group, bleeding volume, oxygen saturation. Half of the patients are marked with tantalum pellets for radiostereometric analysis (RSA). Biomarkers.
Postoperatively:
Standard X-ray. On the patients marked with tantalum pellets RSA is performed. Bone density scan (DXA). Measurements regarding cognition, ADL, mobilization. Eventual confusion is noted. Biomarkers every second day until discharge from hospital. Eventual wound infections or thromboembolic episodes are noted.
Follow up:
Outpatient return visits to physician 3, 6 months, 1, 2, 5, 7, 10 years postoperatively. Standard X-ray, RSA, DXA, Patient questionnaires regarding patient's satisfaction, QoL, activity level, hip function. Biomarkers.
Eventual gains with an uncemented prosthesis:
Reduced fatty embolism risk, reduced inflammatory response, reduced generalized symptoms/confusion, faster mobilization, shorter surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uncemented HA Coated Corail stem | Active comparator | Procedure: Total Hip Arthroplasty, Device: Uncemented HA Coated Corail stemSurgery with an inversed hybrid arthroplasty with an uncemented hydroxyapatite coated Corail stem and a cemented Marathon cup (DePuy). |
| Cemented Lubinus SPII stem (control arm) | Active comparator | Procedure: Total Hip Arthroplasty, Device: Cemented Lubinus SPII stem (control arm)Surgery with a totally cemented option with a Lubinus SPII stem and a IP cup (Link). |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are acutely admitted to hospital with dislocated femoral neck fractures, that in clinical praxis are in the need of hip prosthesis surgery, are recruited in the study. The fracture shall not engage the lesser nor the greater trochanters.
- Patients who wants to participate in the study and who can consider participation for at least 1 year.
- Coming from independent dwelling conditions.
- Not dementia.
- Circa 60-85 years of age.
Key exclusion criteria (7 listed)
- Patients who have difficulties in understanding the intent of the study.
- Rheumatic disorders (RA, Bechterew, SLE).
- Cortison treatment.
- Stroke with remaining weakness or neurological disorders with affection of locomotion.
- Dementia.
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 Arthroplasty | Procedure or surgery | Cemented Lubinus SPII stem (control arm), Uncemented HA Coated Corail stem |
| Cemented Lubinus SPII stem (control arm)Cemented Lubinus femoral stem. Cemented IP acetabular cup. (Link). | Device | Cemented Lubinus SPII stem (control arm) |
| Uncemented HA Coated Corail stemUncemented hydroxyapatite coated Corail femoral stem. Cemented Marathon acetabular cup. (DePuy). | Device | Uncemented HA Coated Corail stem |
Primary outcome
Time to mobilization.
Time frame: During hospital stay, an expected average of 10 days.
Time (days) to mobilization defined as independent walking with or without walking aids measured by ward physiotherapist with Traffic Light System and Sahlgrenska University Hospital Hip Score (SUHS).
7 secondary outcomes
Cognitive status. Eventual confusion.
Time frame: During hospital stay, an expected average of 10 days.
Oxygen saturation levels peroperatively.
Time frame: Peroperatively (during surgery), an expected average of 2 hours.
Bone remodeling around the hip prosthesis.
Time frame: Postoperatively in average after 2 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.
Biomarkers / inflammatory response.
Time frame: Preoperatively in average 4 hours. Peroperatively at end of wound closure. Postoperatively 1, 3, 5, 7 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.
Fixation / migration / loosening of the hip prosthesis components.
Time frame: Postoperatively in average after 2 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.
Reoperation.
Time frame: Postoperatively up to 10 years.
PROM - Patient Reported Outcome Measurements.
Time frame: Preoperatively in average 4 hours. Postoperatively at discharge from hospital at an expected average of 10 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.
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 24 Sep 2020.
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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.
Johan Kärrholm, Prof MD PhD study director
Orthopaedic Department, Sahlgrenska University Hospital, Gothenburg, SWEDEN
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 and Uncemented HA Coated Corail stem in people with Femoral Neck Fractures, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 6 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 24 Sep 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 Sweden. 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?
Time to mobilization. (time frame: During hospital stay, an expected average of 10 days.). 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 24 Sep 2020.