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RCT Comparing Ion Levels and Clinical Outcomes of A-Class BFH to Metal on Polyethylene Total Hip Replacement

NCT00911599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-03-04

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Blood metal ion levels

Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    collaborator INDUSTRY

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Paul E Beaule, MD, FRCSC · University of Ottawa / The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2012-05-31
Completion
2013-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00911599 on ClinicalTrials.gov