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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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

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Hip Joint Osteoarthritis Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conserve Total Hip with BFH

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.

Group Type ACTIVE_COMPARATOR

Blood metal ion levels

Intervention Type DIAGNOSTIC_TEST

Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.

Metal with Polyethylene Liner

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.

Group Type ACTIVE_COMPARATOR

Blood metal ion levels

Intervention Type DIAGNOSTIC_TEST

Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.

Interventions

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Blood metal ion levels

Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No