Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty

Phase 4CompletedNCT01522014

University of Alberta92 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Total Hip Replacement

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Alberta Hospital

Edmonton, Alberta, Canada

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score

This is a disease-specific, patient reported outcome measure of pain.

Time frame: Five Years

WOMAC Function Score

This is a disease-specific patient reported outcome measure of function

Time frame: Five years

WOMAC Stiffness Score

This is a disease-specific, patient-reported outcome measure of stiffness.

Time frame: Five Years

Secondary Outcomes

WOMAC Pain Score

This is a disease-specific, patient-reported outcome measure of pain.

Time frame: One Year

WOMAC Function Score

This is a disease-specific, patient-reported outcome measure of function.

Time frame: One Year

WOMAC Stiffness Score

This is a disease-specific, patient-reported outcome measure of stiffness.

Time frame: One Year

RAND 12-Item Health Survey (RAND-12)

This is a generic patient-reported outcome measure of health status.

Time frame: Five Years

RAND-12

This is a generic patient-reported outcome measure of health status.

Time frame: One years

Complications

This measured the postoperative complications.

Time frame: Five Years

Revisions

This measured the number of revisions in five years

Time frame: Five Years

WOMAC Pain Score

Time frame: 10 Years

WOMAC Function Scores

Time frame: 10 years

WOMAC Stiffness Score

Time frame: 10 years

RAND-12

Time frame: 10 years

Complications

Time frame: 10 years

Revision Rate

Time frame: 10 years

Data from ClinicalTrials.gov

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