An MRI Investigation of Soft Tissues in Total Hip Arthroplasty

• Conditions: Tissue Reaction; Elevated Blood Ion Levels

• Registration Number: NCT01750606
• Lead Sponsor: Zimmer Biomet

Brief 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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Status Verified: 2016-07
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

• patient meets the sampling plan requirements

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of symptomatic and asymptomatic Metal-on-Metal and Metal-on-Poly patients (via a proportion) with a soft tissue mass	patients 3 years post-implantation up to 6 years post implantation	Compare the proportion of symptomatic and asymptomatic Metal-on-Metal patients with a soft tissue mass to the proportion of Metal-on-Poly patients with soft tissue masses.

Secondary Outcome Measures

Name	Time	Method
Metal ion concentrations in whole blood and serum	1-10 year post implantation, depending on cohort	Determine metal ion concentrations in whole blood and serum and assess whether findings correlate to any other variable such as pain, implant type, time since surgery and presence of ALTR.

Trial Locations

Locations (5)

Ortho Michigan; 🇺🇸 Flint, Michigan, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Joint Implant Surgeons; 🇺🇸 New Albany, Ohio, United States

Texas Center for Joint Replacement; 🇺🇸 Plano, Texas, United States

Midlands Orthopaedics; 🇺🇸 Columbia, South Carolina, United States