Clinical trial NCT01522014: Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Hip Replacement
Keywords: Joint Replacement
Health Related Quality of Life
Functional Outcomes
Revision Rate
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Stryker Canada LP
First posted: 2012-01-31
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score
timeFrame: Five Years
measure: WOMAC Function Score
timeFrame: Five years
measure: WOMAC Stiffness Score
timeFrame: Five Years
Secondary outcomes:
measure: WOMAC Pain Score
timeFrame: One Year
measure: WOMAC Function Score
timeFrame: One Year
measure: WOMAC Stiffness Score
timeFrame: One Year
measure: RAND 12-Item Health Survey (RAND-12)
timeFrame: Five Years
measure: RAND-12
timeFrame: One years
measure: Complications
timeFrame: Five Years
measure: Revisions
timeFrame: Five Years
measure: WOMAC Pain Score
timeFrame: 10 Years
measure: WOMAC Function Scores
timeFrame: 10 years
measure: WOMAC Stiffness Score
timeFrame: 10 years
measure: RAND-12
timeFrame: 10 years
measure: Complications
timeFrame: 10 years
measure: Revision Rate
timeFrame: 10 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Lauren Beaupre, PT, PhD
role: STUDY_DIRECTOR
affiliation: Alberta Health services
name: D William C Johnston, MD, FRCS (C)
role: PRINCIPAL_INVESTIGATOR
References: