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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01750606
First received: November 6, 2012
Last updated: July 28, 2014
Last verified: December 2013
  Purpose

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.


Condition
Tissue Reaction
Elevated Blood Ion Levels

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An MRI Investigation of Soft Tissues in Total Hip Arthroplasty

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Number of symptomatic and asymptomatic Metal-on-Metal and Metal-on-Poly patients (via a proportion) with a soft tissue mass [ Time Frame: patients 3 years post-implantation up to 6 years post implantation ] [ Designated as safety issue: Yes ]
    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:
  • Metal ion concentrations in whole blood and serum [ Time Frame: 1-10 year post implantation, depending on cohort ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 436
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • patient meets the sampling plan requirements

Exclusion Criteria:

  • patient is contraindicated for MRI
  • patient fails to consent for the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750606

Locations
United States, Michigan
Ortho Michigan
Flint, Michigan, United States, 48507
United States, Ohio
Joint Implant Surgeons
New Albany, Ohio, United States, 43054
United States, Texas
Texas Center for Joint Replacement
Plano, Texas, United States, 75093
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Director: Russell Schenck, Ph.D. Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01750606     History of Changes
Other Study ID Numbers: ORTHO.CR.GH04, PS110005-28
Study First Received: November 6, 2012
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 14, 2014