An MRI Investigation of Soft Tissues in Total Hip Arthroplasty

Completed

Conditions studied: Tissue Reaction, Elevated Blood Ion Levels

In brief

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.

Key facts

Study ID

NCT01750606

Run by

Zimmer Biomet

People needed

397

Starts

2012-10-01

Expected to finish

2016-09-01

Last updated by the study team

2026-02-20

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• patient meets the sampling plan requirements

You may not qualify if…

• patient is contraindicated for MRI
• patient fails to consent for the study

Where it is running

• Ortho Michigan — Flint, Michigan, United States
• Joint Implant Surgeons — New Albany, Ohio, United States
• Midlands Orthopaedics — Columbia, South Carolina, United States
• Texas Center for Joint Replacement — Plano, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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