N/A
Completed N=406
An MRI Investigation of Soft Tissues in Total Hip Arthroplasty
Tissue Reaction · Elevated Blood Ion Levels
Source: ClinicalTrials.gov NCT01750606 ↗
Enrolled (actual)
406
Serious AEs
100.0%
Results posted
Feb 2026
Primary outcomePrimary: Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass — 1; 5; 22; 23 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass |
1; 5; 22; 23; 1; 8 | — |
| SECONDARY Number of Participants With Metal Ion Concentrations in Whole Blood and Serum > 7ppb |
0; 1; 3; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- patient meets the sampling plan requirements
Exclusion Criteria
- patient is contraindicated for MRI
- patient fails to consent for the study
Data sourced from ClinicalTrials.gov (NCT01750606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.