A Clinical Trial of a Metal on Poly Component Versus CORAIL Stem: A Bone Mineral Density Study
|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 ]
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|