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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Hip Joint, Osteoarthritis, Arthroplasty

Intervention / Treatment
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* Diagnostic Test: Blood metal ion levels


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conserve Total Hip with BFH<br>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. | Diagnostic Test: Blood metal ion levels<br>* Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.<br>|
| Active Comparator: Metal with Polyethylene Liner<br>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. | Diagnostic Test: Blood metal ion levels<br>* Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metal ion levels | To compare the metal ion levels between the advanced metal system and the traditional metal on polyethylene total hip replacement system. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dislocation Rate | Radiographic images will be taken to evaluate dislocation rate | 24 months | 
| Complications | All complications will be continually recorded. | 24 months | 
| Change in Harris Hip Score | Hip disability will be assessed using the Harris Hip Score. The questionnaire is one of the most commonly used hip scores for assessment of hip function. It comprises of 10 sections: Pain, Support, Limp, Distance walked, Stairs, Public Transportation, Sitting, Putting on Shoes/Socks, Presence of Deformity and Range of Motion (flexion, extension, abduction, adduction, internal and external rotation. The score of these items are summed together to get the total score. Scoring can range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent. | 24 months | 
| Change in RAND-36 Health Survey | Health status will be assessed using the RAND-36 Health Survey. The survey contains eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item referring to a perceived change in health. A high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range. The lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. | 24 months | 
| Change in UCLA Questionnaire | Patient-reported activity level will be assessed using the UCLA questionnaire. The index is self-administered and assesses current activity level. The UCLA scale is a simple scale ranging from 1 to 10. A low number (1) signifies very low activity levels, whereas 10 signifies a high activity level. One number is selected to best reflect the participants current activity level. | 24 months | 
| Change in WOMAC Questionnaire | Patient-reported hip functionality will be assessed using the WOMAC questionnaire. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used as a standard assessment of arthritis in the hip joint. The Index is self-administered and assesses the three dimensions of pain (5 items), joint stiffness (2 items), and Physical Function (17 items) in hip osteoarthritis using 24 questions. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. Scores are summed with higher scores indicating worse pain, stiffness, and function. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Individuals undergoing unilateral total hip replacement.