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| Name | Class |
|---|---|
| Stryker Canada LP | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceramic on Ceramic | Active Comparator | Subjects received a ceramic on ceramic bearing total hip replacement. |
|
| Ceramic-on-Highly Crosslinked Polyethylene | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head | Device |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Beaupre, PT, PhD | University of Alberta | Study Director |
| D William C Johnston, MD, FRCS (C) | Alberta Health services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada | ||
| Royal Alexandra Hospital |
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| Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head | Device |
|
| 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 |
| Edmonton |
| Alberta |
| Canada |