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.

Study Overview

• Status: Completed
• Conditions: Total Hip Replacement
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Royal Alexandra Hospital
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications		10 years
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.	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
Revision Rate		10 years

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Stryker Canada LP
• Investigators: Principal Investigator: D William C Johnston, MD, FRCS (C), Alberta Health Services

Study record dates

Study Major Dates

• Study Start: November 1, 1997
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: January 26, 2012
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimate): January 31, 2012

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Joint Replacement; Health Related Quality of Life; Functional Outcomes; Revision Rate
• Other Study ID Numbers: Pro00000886