Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty

Study Overview
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Brief Summary
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Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the geriatric population. Numerous studies have reported good mid and long term results of THA in patients over the age of 60 years. With the reported high success rate of this surgical intervention, the THA surgery is being performed in younger patients who have significant joint disease. A clinical trial, using a randomized blinded design, was undertaken to compare the functional outcome of 1) alumina heads/alumina liners, and 2) alumina head/Crossfire polyethylene liners in patients 60 years of age or younger with non-inflammatory arthritis of the hip. Subjects were assessed preoperatively and at one and five years postoperatively. Ten-year follow-up is currently underway. The primary outcome measure is the WOMAC Osteoarthritis Index. Secondary measures were the RAND-12, as well as measurement of complication and revision rates. The patient's demand on the implant as calculated by the patient's age, weight, health status and activity level was also measured.

Official Title
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Five-Year Outcome of Ceramic on Ceramic Bearing Versus Ceramic on Crossfire® Highly Cross-Linked Polyethylene Bearing in Primary Total Hip Arthroplasty: A Randomized Trial

Conditions
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Total Hip Replacement

Intervention / Treatment
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* Device: Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head
* Device: Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females scheduled for primary THA to treat non-inflammatory arthritis Less than 61 years old at time of surgery Able to speak and read the English language or have an available translator Dorr Index A or B bone quality on preoperative radiographs Willing and able to return for follow-up visits Exclusion Criteria: Have femoral or acetabular bone deficiency requiring augmentation Ongoing corticosteroid use Dorr Index C bone quality on the preoperative radiograph Required a prosthesis neck length of greater than five millimeters

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ceramic on Ceramic<br>Subjects received a ceramic on ceramic bearing total hip replacement. | Device: Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head<br> <br> |
| Active Comparator: Ceramic-on-Highly Crosslinked Polyethylene<br> | Device: Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score | This is a disease-specific, patient reported outcome measure of pain. | Five Years | 
| WOMAC Function Score | This is a disease-specific patient reported outcome measure of function | Five years | 
| WOMAC Stiffness Score | This is a disease-specific, patient-reported outcome measure of stiffness. | Five Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Pain Score | This is a disease-specific, patient-reported outcome measure of pain. | One Year | 
| WOMAC Function Score | This is a disease-specific, patient-reported outcome measure of function. | One Year | 
| WOMAC Stiffness Score | This is a disease-specific, patient-reported outcome measure of stiffness. | One Year | 
| RAND 12-Item Health Survey (RAND-12) | This is a generic patient-reported outcome measure of health status. | Five Years | 
| RAND-12 | This is a generic patient-reported outcome measure of health status. | One years | 
| Complications | This measured the postoperative complications. | Five Years | 
| Revisions | This measured the number of revisions in five years | Five Years | 
| WOMAC Pain Score |  | 10 Years | 
| WOMAC Function Scores |  | 10 years | 
| WOMAC Stiffness Score |  | 10 years | 
| RAND-12 |  | 10 years | 
| Complications |  | 10 years | 
| Revision Rate |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Joint Replacement, Health Related Quality of Life, Functional Outcomes, Revision Rate