Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty

Total Hip Replacement Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522014
• Other study ID #: Pro00000886
• Status: Completed
• Phase: Phase 4
• Start date: November 1997
• Est. completion date: June 2009

Study information

• Verified date: July 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• 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

• Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Stryker Canada LP

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score	This is a disease-specific, patient reported outcome measure of pain.	Five Years
Primary	WOMAC Function Score	This is a disease-specific patient reported outcome measure of function	Five years
Primary	WOMAC Stiffness Score	This is a disease-specific, patient-reported outcome measure of stiffness.	Five Years
Secondary	WOMAC Pain Score	This is a disease-specific, patient-reported outcome measure of pain.	One Year
Secondary	WOMAC Function Score	This is a disease-specific, patient-reported outcome measure of function.	One Year
Secondary	WOMAC Stiffness Score	This is a disease-specific, patient-reported outcome measure of stiffness.	One Year
Secondary	RAND 12-Item Health Survey (RAND-12)	This is a generic patient-reported outcome measure of health status.	Five Years
Secondary	RAND-12	This is a generic patient-reported outcome measure of health status.	One years
Secondary	Complications	This measured the postoperative complications.	Five Years
Secondary	Revisions	This measured the number of revisions in five years	Five Years
Secondary	WOMAC Pain Score		10 Years
Secondary	WOMAC Function Scores		10 years
Secondary	WOMAC Stiffness Score		10 years
Secondary	RAND-12		10 years
Secondary	Complications		10 years
Secondary	Revision Rate		10 years