A Clinical Trial of a Metal on Poly Component Versus CORAIL Stem: A Bone Mineral Density Study
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|ClinicalTrials.gov Identifier: NCT01558752|
Recruitment Status : Active, not recruiting
First Posted : March 20, 2012
Last Update Posted : March 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Total Hip Arthroplasty||Device: Total hip replacement with titanium shell and CORAIL stem Device: Total hip replacement with Modular Titanium Femoral Stem||Not Applicable|
The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). The investigators expect the CORAIL femoral stem group to show significantly less bone loss on the femoral side as compared to the Tri-lock group. The primary outcome is percent change in bone mineral density (BMD) (g/cm2) from baseline (10-14 days post-op) to the one year post-operative interval, as measured radiographically in zones 1 and 7.
Patients will be randomized to one of the two treatment groups prior to surgery. Each patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following surgery.
Bilateral DEXA bone mineral density tests will be performed at 10-14 days following surgery (baseline assessment) and at 6, 12, and 24 months post-operatively.
Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight fast.
The Harris Hip Score will be completed at each post-operative visit except the immediate (10-14 days), when risk of dislocation precludes a determination of range of motion. At the 3, 6, 12 and 24 month post-operative visits, the patient will complete the RAND-36 Item Health Survey, WOMAC and UCLA activity scale.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||A Randomized Clinical Trial of a Modular Cementless Acetabular Metal on Poly Component Versus a Monoblock Cementless Titanium Shell With Ceramic on Ceramic Bearing and CORAIL Stem: A Bone Mineral Density Study|
|Actual Study Start Date :||April 2010|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Titanium Shell with CORAIL stem
Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem.
Device: Total hip replacement with titanium shell and CORAIL stem
Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion).
Active Comparator: Modular Titanium Femoral Stem (Tri-Lock)
Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock).
Device: Total hip replacement with Modular Titanium Femoral Stem
Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert).
- Bone Mineral Density [ Time Frame: 1 Year Post-operative ]
- Osteoclast Activity (N-telopeptides of Type-I collagen) [ Time Frame: 1 Year post-operative ]
- Implant migration [ Time Frame: 2 years post-operative ]Stem and cup migration measured using EBRA-FCA software
- Harris Hip Score [ Time Frame: 2 Years post-operative ]
- RAND-36 Questionnaire [ Time Frame: 2 Years post-operative ]
- WOMAC Questionnaire [ Time Frame: 2 Years post-operative ]
- UCLA Activity Scale [ Time Frame: 2 Years post-operatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558752
|The Ottawa Hospital - General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Paul E Beaulé, MD, FRCSC||Ottawa Hospital Research Institute|