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

Zimmer Biomet

Status: Unknown

Conditions: Elevated Blood Ion Levels; Tissue Reaction

Study type: Observational

Funder types: Industry

Identifiers

NCT01750606

ORTHO.CR.GH04

PS110005-28 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 436 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patient meets the sampling plan requirements

Exclusion criteria

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

Trial design

436 participants in 6 patient groups

pre-THA

Description:

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

Description:

Patients receiving a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006.

M2a Magnum hip

Description:

Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2011.

M2a38 hip

Description:

Patients receiving a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006.

M2a Ringloc hip

Description:

Patients receiving a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004.

M2a Taperloc hip

Description:

Patients receiving a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003.