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NCT02208271 · ClinicalTrials.gov registry record
A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty
A clinical trial, sponsored by OrthoCarolina Research Institute.
- Terminated
- Registry status
- 174
- Enrollment target
NCT02208271: Clinical Trial study, sponsored by OrthoCarolina Research Institute.
NCT02208271 is a clinical trial that was terminated before completion, run by OrthoCarolina Research Institute. The registered enrollment target is 174 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02208271 was terminated before completion, sponsored by OrthoCarolina Research Institute.
- TERMINATED
- Registry status
- 174 participants
- Enrollment target
Study Summary
The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement. A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant, control group) will be enrolled. Preoperative blood serum samples and intraoperative synovial fluid will be obtained from all hips and used for biomarker testing. Additionally, intraoperative assessment of tissue necrosis will be assessed.
Primary Outcome
Blood Serum and Synovial fluid will be tested using a multi-analyte assay test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2014-08-04 |
| Est. Completion | 2020-08-12 |
Why NCT02208271 stopped before completion
NCT02208271 is an observational study that tracks outcomes without assigning an intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02208271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02208271 about?
NCT02208271 is a clinical study titled "A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty". The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement. A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal revision hips, 25 metal-...
What is the current status of trial NCT02208271?
This trial is currently terminated. The enrollment target is 174 participants. The study started on 2014-08-04. Estimated completion is 2020-08-12.
Who is sponsoring clinical trial NCT02208271?
This trial is sponsored by OrthoCarolina Research Institute, which has 28 total clinical trials registered on ClinicalTrials.gov.
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