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Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant

NCT00962351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-08-17

No results posted yet for this study

Summary

This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.

Conditions

  • Non-inflammatory Degenerative Joint Disease

Interventions

PROCEDURE

Total Hip Replacement

Sponsors & Collaborators

  • University of Western Ontario, Canada

    collaborator OTHER

  • DePuy Orthopaedics

    collaborator INDUSTRY

  • Anderson Orthopaedic Research Institute

    lead OTHER

Principal Investigators

  • C. Anderson Engh, Jr., MD · Anderson Orthopaedic Research Institute

  • Steven J. MacDonald, MD · Department of Orthopaedic Surgery, University of Western Ontario

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2010-10-31
Completion
2013-10-31

Countries

  • United States
  • Canada

Study Locations

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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 NCT00962351 on ClinicalTrials.gov