Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty
- Conditions
- Total Hip Replacement
- Interventions
- Device: Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper headDevice: Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head
- Registration Number
- NCT01522014
- Lead Sponsor
- University of Alberta
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ceramic-on-Highly Crosslinked Polyethylene Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head - Ceramic on Ceramic Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head Subjects received a ceramic on ceramic bearing total hip replacement.
- Primary Outcome Measures
Name Time Method WOMAC Function Score Five years This is a disease-specific patient reported outcome measure of function
Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score Five Years This is a disease-specific, patient reported outcome measure of pain.
WOMAC Stiffness Score Five Years This is a disease-specific, patient-reported outcome measure of stiffness.
- Secondary Outcome Measures
Name Time Method Revisions Five Years This measured the number of revisions in five years
WOMAC Stiffness Score 10 years Complications 10 years RAND 12-Item Health Survey (RAND-12) Five Years This is a generic patient-reported outcome measure of health status.
WOMAC Pain Score 10 Years WOMAC Function Score One Year This is a disease-specific, patient-reported outcome measure of function.
RAND-12 10 years Revision Rate 10 years WOMAC Function Scores 10 years
Trial Locations
- Locations (2)
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada