NCT00911599

RCT Comparing Ion Levels and Clinical Outcomes of A-Class BFH to Metal on Polyethylene Total Hip Replacement

A Prospective Randomized Clinical Trial Comparing Ion Levels and Clinical Outcomes of the CONSERVE® A-Class Total Hip System With BFH® Technology to Metal on Polyethylene Total Hip Replacement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this prospective randomized controlled trial is to compare the concentrations of metal ions in the blood and urine of patients receiving implants that are identical except for the acetabular component: one is a monoblock and all cobalt chrome, and the other is modular with a titanium acetabular shell with a polyethylene insert.

Detailed description

The primary aim of this study is to demonstrate that blood ion levels (cobalt and chromium) are lower at one year in patients who receive a metal on polyethylene total hip as compared to CONSERVE® A-Class Total Hip with BFH® technology. Secondary aims include the gathering of clinical data regarding survival and dislocation rates at two years post surgery, as well as the assessment of pain, physical function, radiographic and clinical outcome at the two year interval.

Conditions

• Hip Joint
• Osteoarthritis
• Arthroplasty

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood metal ion levels	Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.

Timeline

• Start date: 2006-08-01
• Primary completion: 2012-05-01
• Completion: 2013-05-01
• First posted: 2009-06-02
• Last updated: 2020-03-04

Locations

1 site across 1 country: Canada