At a glance
ClinicalIndex Comparison RecordN/ACompleted· 397 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An MRI Investigation of Soft Tissues in Total Hip Arthroplasty
In Brief
An observational study for Tissue Reaction and Elevated Blood Ion Levels. Completed, enrolled 397 participants across 5 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsTissue Reaction, Elevated Blood Ion Levels
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedDec 2012
Primary CompletionJul 2016
Study CompletionSep 2016
TodayJul 2026
First PostedDec 17, 2012
Enrollment StartOct 1, 2012
Primary CompletionJul 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.5 years ago