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NCT04594993 · ClinicalTrials.gov registry record
INFINITY™ With ADAPTIS™ Technology Study
A clinical trial of Arthritis, Rheumatoid, sponsored by Stryker Trauma and Extremities.
- Active
- Registry status
- 200
- Enrollment target
- 13
- Study locations
NCT04594993: Active study of Arthritis, Rheumatoid, sponsored by Stryker Trauma and Extremities.
NCT04594993 is a study of Arthritis, Rheumatoid that is active but no longer recruiting, run by Stryker Trauma and Extremities. The registered enrollment target is 200 participants, below the 634-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (68% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04594993, a study of Arthritis, Rheumatoid, is active but no longer recruiting, sponsored by Stryker Trauma and Extremities.
- ACTIVE NOT RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 13
- Study locations
Study Summary
INFINITY™ with ADAPTIS™ Technology Total Ankle Replacement Follow-up (ITAR2) - Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 200 patients with up to 13 sites
Primary Outcome
Assess the 10-year survivorship of 200 patients implanted with the INFINITY™ with ADAPTIS™ Technology Total Ankle System is non-inferior to other, similar devices.
Conditions Studied
Interventions
- DEVICE INFINITY™ with ADAPTIS™ Technology Total Ankle System
Study Locations (13)
Tennessee
- Erlanger Institute for Clinical Research - Chattanooga
- Campbell Clinic - Germantown
- Vanderbilt University Medical Center - Nashville
Colorado
- University of Colorado Orthopedic Research Center - Aurora
- Steadman Philippon Research Institute - Vail
Oregon
- Slocum Center for Orthopedics & Sports Medicine - Eugene
- Southern Oregon Orthopedics - Medford
Arizona
- OrthoArizona Foot and Ankle Institute - Gilbert
California
- Eisenhower Health / Desert Orthopedic Center - Rancho Mirage
Florida
- Florida Joint Care Institute - Trinity
Illinois
- Loyola University Medical Center - Maywood
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2035-11 |
What the registry record for NCT04594993 still lists
NCT04594993 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 634-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 1 intervention - of which INFINITY™ with ADAPTIS™ Technology Total Ankle System is the first listed.
NCT04594993 lists 13 locations in 9 states (Tennessee, Colorado, Oregon).
Frequently Asked Questions
What is clinical trial NCT04594993 about?
NCT04594993 is a clinical study titled "INFINITY™ With ADAPTIS™ Technology Study". INFINITY™ with ADAPTIS™ Technology Total Ankle Replacement Follow-up (ITAR2) - Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 200...
What is the current status of trial NCT04594993?
This trial is currently active not recruiting. The enrollment target is 200 participants. The study started on 2021-02-09. Estimated completion is 2035-11.
What conditions does trial NCT04594993 study?
This clinical trial studies the following conditions: Arthritis, Rheumatoid.
What interventions are being tested in trial NCT04594993?
The interventions under investigation include: INFINITY™ with ADAPTIS™ Technology Total Ankle System (DEVICE).
Who is sponsoring clinical trial NCT04594993?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04594993 being conducted?
This trial has 13 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04594993's enrollment target sits among peer trials
200 16th of 27 higher than 11 of 27 other Arthritis, Rheumatoid trials
participants (enrollment target), bucketed by value
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