NCT01558752

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Hip Arthroplasty

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2010-04-01
• Primary completion: 2019-07-31
• Completion: 2020-11-20
• First posted: 2012-03-20
• Last updated: 2020-12-19
• Results posted: 2020-12-19

Locations

1 site across 1 country: Canada