NCT01750606

An MRI Investigation of Soft Tissues in Total Hip Arthroplasty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 397 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

This study has been designed to estimate the prevalence of soft tissue changes following primary THA surgery in patients having received one of five Biomet implant types; a MOP primary THA, an M2a 38, M2a Taper, M2a Ringloc and M2a Magnum MOM primary THA device in 308-436 total patients at four centers. The primary objective of the study is to estimate the prevalence of soft tissue changes in unbiased MoM and MoP samples. Secondary objectives are to evaluate whether the occurrence of soft tissue changes is related to any of several potential covariates including patient and implant characteristics and time in situ.

Conditions

• Tissue Reaction
• Elevated Blood Ion Levels

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2012-12-17
• Last updated: 2026-02-20
• Results posted: 2026-02-20

Locations

5 sites across 1 country: United States