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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522014

Locations
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
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) AHS Cancer Control Alberta
  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 October 22, 2014