Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty
This study has been completed.
Sponsor:
University of Alberta
Collaborator:
Stryker Canada
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01522014
First received: January 26, 2012
Last updated: February 19, 2013
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 Device: Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by University of Alberta:
Primary Outcome Measures:
- Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score [ Time Frame: Five Years ] [ Designated as safety issue: No ]This is a disease-specific, patient reported outcome measure of pain.
- WOMAC Function Score [ Time Frame: Five years ] [ Designated as safety issue: No ]This is a disease-specific patient reported outcome measure of function
- WOMAC Stiffness Score [ Time Frame: Five Years ] [ Designated as safety issue: No ]This is a disease-specific, patient-reported outcome measure of stiffness.
Secondary Outcome Measures:
- WOMAC Pain Score [ Time Frame: One Year ] [ Designated as safety issue: No ]This is a disease-specific, patient-reported outcome measure of pain.
- WOMAC Function Score [ Time Frame: One Year ] [ Designated as safety issue: No ]This is a disease-specific, patient-reported outcome measure of function.
- WOMAC Stiffness Score [ Time Frame: One Year ] [ Designated as safety issue: No ]This is a disease-specific, patient-reported outcome measure of stiffness.
- RAND 12-Item Health Survey (RAND-12) [ Time Frame: Five Years ] [ Designated as safety issue: No ]This is a generic patient-reported outcome measure of health status.
- RAND-12 [ Time Frame: One years ] [ Designated as safety issue: No ]This is a generic patient-reported outcome measure of health status.
- Complications [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]This measured the postoperative complications.
- Revisions [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]This measured the number of revisions in five years
- WOMAC Pain Score [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
- WOMAC Function Scores [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- WOMAC Stiffness Score [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- RAND-12 [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Complications [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- Revision Rate [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 92 |
| Study Start Date: | November 1997 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ceramic on Ceramic
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 |
| Active Comparator: Ceramic-on-Highly Crosslinked Polyethylene | Device: Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522014
Locations
| Canada, Alberta | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Royal Alexandra Hospital | |
| Edmonton, Alberta, Canada | |
Sponsors and Collaborators
University of Alberta
Stryker Canada
Investigators
| Study Director: | Lauren Beaupre, PT, PhD | University of Alberta |
| Principal Investigator: | D William C Johnston, MD, FRCS (C) | Alberta Health Services |
More Information
No publications provided
| Responsible Party: | University of Alberta |
| ClinicalTrials.gov Identifier: | NCT01522014 History of Changes |
| Other Study ID Numbers: | Pro00000886 |
| Study First Received: | January 26, 2012 |
| Last Updated: | February 19, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Alberta:
|
Joint Replacement Health Related Quality of Life Functional Outcomes Revision Rate |
ClinicalTrials.gov processed this record on June 17, 2013