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

Ottawa Hospital Research Institute

Status: Completed

Conditions: Hip Joint; Osteoarthritis; Arthroplasty

Treatments: Diagnostic Test: Blood metal ion levels

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00911599

2006-506

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals undergoing unilateral total hip replacement.
• Patients 50 to 70 years of age.

Exclusion criteria

• Patients who have previously undergone any type of joint replacement.
• Patients with evidence of active infection.
• Patients with a documented allergy to cobalt chromium molybdenum.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Conserve Total Hip with BFH

Active Comparator group

Description:

CONSERVE® A-Class Total Hip with BFH technology. Blood and urine samples will be collected and blood metal ion levels will be analyzed and compared to samples from the other group.

Treatment:

Diagnostic Test: Blood metal ion levels

Metal with Polyethylene Liner

Active Comparator group

Description:

Metal on polyethylene total hip replacement. Blood and urine samples will be collected and blood metal ion levels will be analyzed and compared to samples from the other group.

Treatment:

Diagnostic Test: Blood metal ion levels