An MRI Investigation of Soft Tissues in Total Hip Arthroplasty (MoM_MRI)

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.

Study Overview

• Status: Completed
• Conditions: Tissue Reaction; Elevated Blood Ion Levels

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.

• Study Type: Observational
• Enrollment (Actual): 397

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48507
      • Ortho Michigan
  • Ohio
    • New Albany, Ohio, United States, 43054
      • Joint Implant Surgeons
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Midlands Orthopaedics
  • Texas
    • Plano, Texas, United States, 75093
      • Texas Center for Joint Replacement
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who have received the indicated implants at one of four participating centers and who meet the sampling plan requirements.

Description

Inclusion Criteria:

• patient meets the sampling plan requirements

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
pre-THA; Patients who are planned but have not yet received a total hip arthroplasty. No intervention or treatment - blood draw only to be used as a surrogate baseline for metal ion exposure.
Metal-on-Poly; Patients receiving a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006.
M2a Magnum hip; Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2011.
M2a38 hip; Patients receiving a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006.
M2a Ringloc hip; Patients receiving a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004.
M2a Taperloc hip; Patients receiving a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass	Determine the percentage of asymptomatic vs symptomatic Metal-on-Metal and Metal-on-Poly patients with a soft tissue mass	Patients 1 year post-implantation up to 10 years post implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Metal Ion Concentrations in Whole Blood and Serum > 7ppb	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.	1 Year through 10 Years Postop

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Russell Schenck, Ph.D., Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimated): December 17, 2012

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ORTHO.CR.GH04; PS110005-28 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED