Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty

This study has been completed.
Sponsor:
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

January 26, 2012
February 19, 2013
November 1997
January 2009   (final data collection date for primary outcome measure)
  • 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.
  • Western Ontario McMaster Osteoarthrits 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.
Complete list of historical versions of study NCT01522014 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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
  • Active Comparator: Ceramic on Ceramic
    Subjects received a ceramic on ceramic bearing total hip replacement.
    Intervention: 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
    Intervention: Device: Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
June 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01522014
Pro00000886
No
University of Alberta
University of Alberta
Stryker Canada
Study Director: Lauren Beaupre, PT, PhD University of Alberta
Principal Investigator: D William C Johnston, MD, FRCS (C) AHS Cancer Control Alberta
University of Alberta
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP