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An MRI Investigation of Soft Tissues in Total Hip Arthroplasty

NCT01750606 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 397

Last updated 2026-02-20

Study results available
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Summary

Retrospective study to comply with FDA's post-market surveillance order. The purpose of the study is to contact patients who have received a Biomet metal-on-metal product as their primary total hip arthroplasty device. Patients who have not been revised prior to contact will be asked to submit to a blood draw, clinical exam and MRI.

Conditions

  • Tissue Reaction
  • Elevated Blood Ion Levels

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Russell Schenck, Ph.D. · Zimmer Biomet

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-07-31
Completion
2016-09-30

Countries

  • United States

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 NCT01750606 on ClinicalTrials.gov