An MRI Investigation of Soft Tissues in Total Hip Arthroplasty (MoM MRI)
This study is enrolling participants by invitation only.
Sponsor:
Biomet, Inc.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01750606
First received: November 6, 2012
Last updated: January 7, 2013
Last verified: January 2013
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Purpose
Per the 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 |
|---|
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Adverse Local Tissue Reactions in Total Hip Arthroplasty |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
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 2014 |
| Estimated Primary Completion Date: | June 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.
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Metal-on-Poly
Patients receiving a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006.
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M2a Magnum hip
Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2011.
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M2a38 hip
Patients receiving a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006.
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M2a Ringloc hip
Patients receiving a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004.
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M2a Taperloc hip
Patients receiving a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003.
|
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 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: | January 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 19, 2013