Clinical trial NCT00911599: RCT Comparing Ion Levels and Clinical Outcomes of A-Class BFH to Metal on Polyethylene Total Hip Replacement
Official title: A Prospective Randomized Clinical Trial Comparing Ion Levels and Clinical Outcomes of the CONSERVE® A-Class Total Hip System With BFH® Technology to Metal on Polyethylene Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Joint
Osteoarthritis
Arthroplasty
Keywords: Individuals undergoing unilateral total hip replacement.
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Stryker Trauma and Extremities
First posted: 2009-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this prospective randomized controlled trial is to compare the concentrations of metal ions in the blood and urine of patients receiving implants that are identical except for the acetabular component: one is a monoblock and all cobalt chrome, and the other is modular with a titanium acetabular shell with a polyethylene insert.

Detailed description: The primary aim of this study is to demonstrate that blood ion levels (cobalt and chromium) are lower at one year in patients who receive a metal on polyethylene total hip as compared to CONSERVE® A-Class Total Hip with BFH® technology. Secondary aims include the gathering of clinical data regarding survival and dislocation rates at two years post surgery, as well as the assessment of pain, physical function, radiographic and clinical outcome at the two year interval.

Eligibility criteria: Inclusion Criteria:

* Individuals undergoing unilateral total hip replacement.
* Patients 50 to 70 years of age.

Exclusion Criteria:

* Patients who have previously undergone any type of joint replacement.
* Patients with evidence of active infection.
* Patients with a documented allergy to cobalt chromium molybdenum.

Primary outcomes:
measure: Metal ion levels
timeFrame: 24 months
Secondary outcomes:
measure: Dislocation Rate
timeFrame: 24 months
measure: Complications
timeFrame: 24 months
measure: Change in Harris Hip Score
timeFrame: 24 months
measure: Change in RAND-36 Health Survey
timeFrame: 24 months
measure: Change in UCLA Questionnaire
timeFrame: 24 months
measure: Change in WOMAC Questionnaire
timeFrame: 24 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital - General Campus
state: Ontario
Study officials:
affiliation: University of Ottawa / The Ottawa Hospital
name: Paul E Beaule, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gofton W, Beaule PE. Serum Metal Ions with a Titanium Modular Neck Total Hip Replacement System. J Arthroplasty. 2015 Oct;30(10):1781-6. doi: 10.1016/j.arth.2015.04.040. Epub 2015 May 9.
citation: Beaule PE, Kim PR, Hamdi A, Fazekas A. A prospective metal ion study of large-head metal-on-metal bearing: a matched-pair analysis of hip resurfacing versus total hip replacement. Orthop Clin North Am. 2011 Apr;42(2):251-7, ix. doi: 10.1016/j.ocl.2011.01.005.