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NCT01284283 · ClinicalTrials.gov registry record · NA
2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use
A NA study of Rheumatoid Arthritis and Osteoarthritis, sponsored by Encore Medical, L.P..
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 9
- Study locations
NCT01284283 is a NA study of Rheumatoid Arthritis and Osteoarthritis that has completed, run by Encore Medical, L.P.. The registered enrollment target is 102 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower). The trial reports 9 study locations across 7 states.
The verdict
NCT01284283, a NA study of Rheumatoid Arthritis and Osteoarthritis, has completed, sponsored by Encore Medical, L.P..
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 9
- Study locations
Study Summary
This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.
Conditions Studied
Interventions
- DEVICE Scandinavian Total Ankle Replacement System (STAR Ankle)
Study Locations (9)
California
- Cedars Sinai Medical Center - Los Angeles
- Palo Alto Medical Research Foundation (Sutter Health) - Palo Alto
- Kaiser Permanente - San Francisco
Arizona
- The CORE Institute - Phoenix
Michigan
- William Beaumont Hospital - Royal Oak
Nevada
- Reno Orthopaedic Center - Reno
New York
- Kenneth Mroczek, MD-NYU - New York
Pennsylvania
- University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons - Philadelphia
Texas
- Center for Foot and Ankle Restoration - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2009-11 |
| Est. Completion | 2021-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01284283
The ClinicalTrials.gov registry entry for NCT01284283 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower). The listed sponsor is Encore Medical, L.P., which has 16 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Scandinavian Total Ankle Replacement System (STAR Ankle) is the first listed.
NCT01284283 reports 9 study locations spanning 7 distinct geographic areas - top geographies include California, Arizona, Michigan.
Frequently Asked Questions
What is clinical trial NCT01284283 about?
NCT01284283 is a clinical study titled "2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use". This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.
What is the current status of trial NCT01284283?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2009-11. Estimated completion is 2021-03.
What conditions does trial NCT01284283 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Osteoarthritis, Post Traumatic Arthritis, Primary Arthrosis.
What interventions are being tested in trial NCT01284283?
The interventions under investigation include: Scandinavian Total Ankle Replacement System (STAR Ankle) (DEVICE).
Who is sponsoring clinical trial NCT01284283?
This trial is sponsored by Encore Medical, L.P., which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01284283 being conducted?
This trial has 9 study locations across Arizona, California, Michigan, Nevada, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.