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NCT01481896 · ClinicalTrials.gov registry record
A Five-Year Metal-on-Metal Retrospective Clinical Study
A clinical trial, sponsored by Anderson Orthopaedic Research Institute.
- Completed
- Registry status
- 126
- Enrollment target
NCT01481896: Completed study, sponsored by Anderson Orthopaedic Research Institute.
NCT01481896 is a clinical trial that has completed, run by Anderson Orthopaedic Research Institute. The registered enrollment target is 126 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01481896 has completed, sponsored by Anderson Orthopaedic Research Institute.
- COMPLETED
- Registry status
- 126 participants
- Enrollment target
Study Summary
This retrospective study will review the Anderson Orthopaedic Institute's initial experience among a consecutive series of 126 patients who had primary total hip arthroplasty using a metal-on-metal articulation consisting of a DePuy Pinnacle cup with an Ultamet liner coupled with a 36-mm cobalt-chrome alloy femoral head. The relationship between metal ion levels, cup orientation, osteolysis, radiographic implant stability and clinical outcome measures including component revision, complications, patient satisfaction and Harris Hip Scores will be evaluated.
Primary Outcome
Metal ion levels include cobalt and chromium ion levels determined from tests of blood samples. Metal ion levels are reported per participant since blood samples were taken from individual participants who could have had one or both hips replaced.
Interventions
- DEVICE Metal-on-metal primary total hip arthroplasty (DePuy )
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-06 |
What the finished NCT01481896 record still lists
NCT01481896 is an observational study that tracks outcomes without assigning an intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Metal-on-metal primary total hip arthroplasty (DePuy ) is the first listed.
NCT01481896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01481896 about?
NCT01481896 is a clinical study titled "A Five-Year Metal-on-Metal Retrospective Clinical Study". This retrospective study will review the Anderson Orthopaedic Institute's initial experience among a consecutive series of 126 patients who had primary total hip arthroplasty using a metal-on-metal articulation consisting of a DePuy Pinnacle cup with an Ultamet liner coupled with a 36-mm cobalt-chro...
What is the current status of trial NCT01481896?
This trial is currently completed. The enrollment target is 126 participants. The study started on 2011-12. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01481896?
The interventions under investigation include: Metal-on-metal primary total hip arthroplasty (DePuy ) (DEVICE).
Who is sponsoring clinical trial NCT01481896?
This trial is sponsored by Anderson Orthopaedic Research Institute, which has 7 total clinical trials registered on ClinicalTrials.gov.
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