Cemented Versus Uncemented Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01578408|
Recruitment Status : Recruiting
First Posted : April 17, 2012
Last Update Posted : May 29, 2015
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.
|Condition or disease||Intervention/treatment|
|Femoral Neck Fractures||Procedure: Total Hip Arthroplasty Device: Cemented Lubinus SPII stem (control arm) Device: Uncemented HA Coated Corail stem|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2023|
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).
Procedure: Total Hip Arthroplasty
Device: Uncemented HA Coated Corail stem
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).
Procedure: Total Hip Arthroplasty
Device: Cemented Lubinus SPII stem (control arm)
Cemented Lubinus femoral stem. Cemented IP acetabular cup. (Link).
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- Reoperation. [ Time Frame: Postoperatively up to 10 years. ]In case of for example infection or dislocation.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578408
|Contact: Arun Patel, MD||+46 31 343 08 email@example.com|
|Contact: Johan Kärrholm, Prof MD PhD||+46 31 342 82 firstname.lastname@example.org|
|Mölndals Hospital (part of Sahlgrenska University Hospital)||Recruiting|
|Mölndal, Sweden, 43180|
|Contact: Arun Patel, MD +46 31 343 08 55 email@example.com|
|Contact: Johan Kärrholm, Prof MD PhD +46 31 342 82 47 firstname.lastname@example.org|
|Principal Investigator: Arun Patel, MD|
|Study Director:||Johan Kärrholm, Prof MD PhD||Orthopaedic Department, Sahlgrenska University Hospital, Gothenburg, SWEDEN|