- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01578408
Cemented Versus Uncemented Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mölndal, Sweden, 43180
- Mölndals Hospital (part of Sahlgrenska University Hospital)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Uncemented HA Coated Corail stem
Surgery with an inversed hybrid arthroplasty with an uncemented hydroxyapatite coated Corail stem and a cemented Marathon cup (DePuy).
|
Uncemented hydroxyapatite coated Corail femoral stem.
Cemented Marathon acetabular cup.
(DePuy).
|
Active Comparator: Cemented Lubinus SPII stem (control arm)
Surgery with a totally cemented option with a Lubinus SPII stem and a IP cup (Link).
|
Cemented Lubinus femoral stem.
Cemented IP acetabular cup.
(Link).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
During hospital stay, an expected average of 10 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive status. Eventual confusion.
Time Frame: During hospital stay, an expected average of 10 days.
|
Cognitive status measured once daily with Pfeiffer's test (Short Portable Mental Status Questionnaire - SPMSQ). Eventual confusion is noted once daily. |
During hospital stay, an expected average of 10 days.
|
Oxygen saturation levels peroperatively.
Time Frame: Peroperatively (during surgery), an expected average of 2 hours.
|
POX-measurements during different phases of surgery along with pulmonary catheter readings.
|
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.
|
Measurements with hip DXA.
|
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.
|
Blood samples for measurement of the inflammatory response with biochip multi-array technology.
|
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.
|
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.
|
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.
|
In case of for example infection or dislocation.
|
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.
|
Questionnaires regarding Patient's satisfaction, Quality of life (EQ-5D), Activity level (UCLA), Harris Hip Score.
|
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.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Johan Kärrholm, Prof MD PhD, Orthopaedic Department, Sahlgrenska University Hospital, Gothenburg, SWEDEN
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Corail-SP Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Femoral Neck Fractures
-
Sundsvall HospitalCompletedFemoral Neck FractureSweden
-
Hospices Civils de LyonCompleted
-
RenJi HospitalRecruiting
-
Sorlandet Hospital HFCompleted
-
Hartford HospitalZimmer BiometCompletedFemoral Neck FractureUnited States
-
First Hospitals affiliated to the China PLA General...Unknown
-
Danderyd HospitalCompletedFemoral Neck FractureSweden
-
Istanbul UniversityCompletedFemoral Neck Fractures | Femoral Neck ShorteningTurkey
-
Hebei Medical University Third HospitalUnknown
-
University Hospital, AngersCompletedFemoral Neck FractureFrance
Clinical Trials on Total Hip Arthroplasty
-
Smith & Nephew, Inc.RecruitingAdvanced Degeneration of the Hip Joint | Revision of the Hip JointUnited States, Canada, Australia, Hong Kong, India
-
Suzhou MicroPort OrthoRecon Co. LTDCompleted
-
DePuy OrthopaedicsTerminatedOsteoarthritis | Degenerative Arthritis | Revision ArthroplastyCanada
-
Rothman Institute OrthopaedicsCompleted
-
Orthopedic Hospital Vienna SpeisingCompletedTotal Hip ArthroplastyAustria
-
Istituto Clinico HumanitasCompleted
-
Norwegian University of Science and TechnologyOrtoMedic A/S, Oslo; Scandinavian Customized Prosthesis (SCP)CompletedOsteoarthritis, Hip
-
NHS LothianTerminatedHip FracturesUnited Kingdom
-
Western University, CanadaNot yet recruiting
-
Zimmer BiometTerminatedJoint Diseases | Osteoarthritis, Hip | Avascular Necrosis of Hip | Congenital Dysplasia of the Hip | Degenerative Joint Disease of Hip | Rheumatoid Arthritis of Hip | Post-Traumatic Osteoarthritis of HipCanada