A Clinical Trial of a Metal on Poly Component Versus CORAIL Stem: A Bone Mineral Density Study
Condition: Total Hip Arthroplasty
Study type: Interventional

Summary: 
      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). 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. Patients will be asked to have bilateral DEXA bone mineral density tests (10-14 days
      post-surgery, and 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. Patient reported questionnaires will be completed preoperatively and at the 3, 6, 12,
      and 24 month visits.
    

Detailed description: 
      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 two 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 DXA 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 SF-36 Item Health
      Survey, WOMAC and UCLA activity scale.
    

Intervention name(s): Total hip replacement with titanium shell and CORAIL stem; Total hip replacement with Modular Titanium Femoral Stem
Intervention type(s): Device; Device
Intervention description(s): 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).; 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).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Total Hip Replacement; Bone Mineral Density; Stem; Dual-energy x-ray absorptiometry; DXA-RFA; Corail; Tri-Lock