Last updated on August 2018

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

Brief description of study

The main goal 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.

Clinical Study Identifier: NCT01558752

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Jae-Jin Ryu, Ph.D

The Ottawa Hospital - General Campus
Ottawa, ON Canada