Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty
NCT ID: NCT01522014
Last Updated: 2021-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
92 participants
INTERVENTIONAL
1997-11-30
2009-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ceramic on Ceramic
Subjects received a ceramic on ceramic bearing total hip replacement.
Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head
Ceramic-on-Highly Crosslinked Polyethylene
Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head
Interventions
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Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head
Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head
Eligibility Criteria
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Inclusion Criteria
* 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
* Ongoing corticosteroid use
* Dorr Index C bone quality on the preoperative radiograph
* Required a prosthesis neck length of greater than five millimeters
18 Years
60 Years
ALL
No
Sponsors
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Stryker Canada LP
INDUSTRY
University of Alberta
OTHER
Responsible Party
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Principal Investigators
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Lauren Beaupre, PT, PhD
Role: STUDY_DIRECTOR
University of Alberta
D William C Johnston, MD, FRCS (C)
Role: PRINCIPAL_INVESTIGATOR
Alberta Health services
Locations
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University of Alberta Hospital
Edmonton, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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Pro00000886
Identifier Type: -
Identifier Source: org_study_id
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