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NCT01750606 · ClinicalTrials.gov registry record
An MRI Investigation of Soft Tissues in Total Hip Arthroplasty
A clinical trial of Tissue Reaction and Elevated Blood Ion Levels, sponsored by Zimmer Biomet.
- Completed
- Registry status
- 397
- Enrollment target
- 5
- Study locations
NCT01750606: Completed study of Tissue Reaction and Elevated Blood Ion Levels, sponsored by Zimmer Biomet.
NCT01750606 is a study of Tissue Reaction and Elevated Blood Ion Levels that has completed, run by Zimmer Biomet. The registered enrollment target is 397 participants. The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01750606, a study of Tissue Reaction and Elevated Blood Ion Levels, has completed, sponsored by Zimmer Biomet.
- COMPLETED
- Registry status
- 397 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Determine the percentage of asymptomatic vs symptomatic Metal-on-Metal and Metal-on-Poly patients with a soft tissue mass
Conditions Studied
Study Locations (5)
Michigan
- Ortho Michigan - Flint
Ohio
- Joint Implant Surgeons - New Albany
South Carolina
- Midlands Orthopaedics - Columbia
Texas
- Texas Center for Joint Replacement - Plano
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 397 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-09 |
What the finished NCT01750606 record still lists
NCT01750606 is an observational study that tracks outcomes without assigning an intervention. The registered 397 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Tissue Reaction appearing as the primary indexed condition, and to 0 interventions.
NCT01750606 lists 5 locations in 5 states (Michigan, Ohio, South Carolina).
Frequently Asked Questions
What is clinical trial NCT01750606 about?
NCT01750606 is a clinical study titled "An MRI Investigation of Soft Tissues in Total Hip Arthroplasty". 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 ...
What is the current status of trial NCT01750606?
This trial is currently completed. The enrollment target is 397 participants. The study started on 2012-10. Estimated completion is 2016-09.
What conditions does trial NCT01750606 study?
This clinical trial studies the following conditions: Tissue Reaction, Elevated Blood Ion Levels.
Who is sponsoring clinical trial NCT01750606?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01750606 being conducted?
This trial has 5 study locations across Michigan, Ohio, South Carolina, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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