Total Hip Replacement
Conditions
Keywords
Joint Replacement, Health Related Quality of Life, Functional Outcomes, Revision Rate
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.
Interventions
DEVICESecure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head
DEVICESecure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head
Sponsors
Stryker Canada LP
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score | Five Years | This is a disease-specific, patient reported outcome measure of pain. |
| WOMAC Function Score | Five years | This is a disease-specific patient reported outcome measure of function |
| WOMAC Stiffness Score | Five Years | This is a disease-specific, patient-reported outcome measure of stiffness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RAND 12-Item Health Survey (RAND-12) | Five Years | This is a generic patient-reported outcome measure of health status. |
| RAND-12 | One years | This is a generic patient-reported outcome measure of health status. |
| Complications | Five Years | This measured the postoperative complications. |
| WOMAC Pain Score | One Year | This is a disease-specific, patient-reported outcome measure of pain. |
| WOMAC Function Scores | 10 years | — |
| Revision Rate | 10 years | — |
| Revisions | Five Years | This measured the number of revisions in five years |
| WOMAC Function Score | One Year | This is a disease-specific, patient-reported outcome measure of function. |
| WOMAC Stiffness Score | One Year | This is a disease-specific, patient-reported outcome measure of stiffness. |
Countries
Canada
Outcome results
None listed