Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty

University of Alberta

Status and phase: Completed; Phase 4

Conditions: Total Hip Replacement

Treatments: 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

Funder types: Other; Industry

Identifiers

NCT01522014

Pro00000886

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

Ceramic on Ceramic

Active Comparator group

Description:

Subjects received a ceramic on ceramic bearing total hip replacement.

Treatment:

Device: Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head

Ceramic-on-Highly Crosslinked Polyethylene

Active Comparator group

Treatment:

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