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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Metal ion levels
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Metal ion levels
Time Frame: 24 months
To compare the metal ion levels between the advanced metal system and the traditional metal on polyethylene total hip replacement system.
Secondary Outcomes
- Dislocation Rate(24 months)
- Complications(24 months)
- Change in Harris Hip Score(24 months)
- Change in UCLA Questionnaire(24 months)
- Change in WOMAC Questionnaire(24 months)
- Change in RAND-36 Health Survey(24 months)