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OpenTrials
Completed

NCT Number: NCT01750606

An MRI Investigation of Soft Tissues in Total Hip Arthroplasty

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.

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Key information

Conditions

Tissue Reaction Elevated Blood Ion Levels

Sex eligibility

All sexes

Study type

Observational

Primary location

Ortho Michigan, Flint, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient meets the sampling plan requirements

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass

    Time frame: Patients 1 year post-implantation up to 10 years post implantation

    Determine the percentage of asymptomatic vs symptomatic Metal-on-Metal and Metal-on-Poly patients with a soft tissue mass

Secondary outcomes

  1. Number of Participants With Metal Ion Concentrations in Whole Blood and Serum > 7ppb

    Time frame: 1 Year through 10 Years Postop

    The outcome measure will show the number of subjects in all post-operative cohorts determined to have metal ion concentrations in whole blood and serum >7ppb in each study arm.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Acronym: MoM_MRI

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2012
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.