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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Total Hip Replacement
- Sponsor
- University of Alberta
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- WOMAC Function Score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
WOMAC Function Score
Time Frame: Five years
This is a disease-specific patient reported outcome measure of function
Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score
Time Frame: Five Years
This is a disease-specific, patient reported outcome measure of pain.
WOMAC Stiffness Score
Time Frame: Five Years
This is a disease-specific, patient-reported outcome measure of stiffness.
Secondary Outcomes
- Revisions(Five Years)
- WOMAC Stiffness Score(10 years)
- Complications(10 years)
- RAND 12-Item Health Survey (RAND-12)(Five Years)
- WOMAC Pain Score(10 Years)
- WOMAC Function Score(One Year)
- RAND-12(10 years)
- Revision Rate(10 years)
- WOMAC Function Scores(10 years)