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NCT02521103 · ClinicalTrials.gov registry record · NA
Triathlon Tritanium Cone Augments Outcomes Study
A NA study of Arthroplasty and Replacement, sponsored by Stryker Orthopaedics.
- Active
- Registry status
- NA
- Development phase
- 145
- Enrollment target
- 9
- Study locations
NCT02521103: Active NA study of Arthroplasty and Replacement, sponsored by Stryker Orthopaedics.
NCT02521103 is a NA study of Arthroplasty and Replacement that is active but no longer recruiting, run by Stryker Orthopaedics. The registered enrollment target is 145 participants, below the 212-participant average among 5 other Arthroplasty trials with a reported enrollment target (32% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02521103, a NA study of Arthroplasty and Replacement, is active but no longer recruiting, sponsored by Stryker Orthopaedics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 145 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments at 2 years postoperative.
Primary Outcome
The primary efficacy parameter is the revision/removal of femoral cone augment or tibial cone augment for aseptic loosening at 2 years postoperative. Success at 2 years is defined as no incidence of revision/removal of femoral or tibial cone augment for aseptic loosening within 2 years.
Conditions Studied
Interventions
- DEVICE Triathlon Tritanium Cone Augments
Study Locations (9)
Michigan
- The CORE Institute - Novi
- Michigan Heart, St. Joseph Health System - Ypsilanti
Florida
- Florida Medical Clinic - Zephyrhills
Illinois
- Rush University Medical Center - Chicago
Kentucky
- Bluegrass Orthopaedics - Lexington
Missouri
- Missouri Orthopaedic Institute - Columbia
New Jersey
- Rothman Institute - Egg Harbor
Oklahoma
- The Orthopaedic Center - Tulsa
Washington
- Providence Medical Research Center - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2015-08 |
| Est. Completion | 2028-03-31 |
| Phase | NA |
What the registry record for NCT02521103 still lists
NCT02521103 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 212-participant average among 5 other Arthroplasty trials with a reported enrollment target (32% lower).
The record links to 3 conditions, with Arthroplasty appearing as the primary indexed condition, and to 1 intervention - of which Triathlon Tritanium Cone Augments is the first listed.
NCT02521103 lists 9 locations in 8 states (Michigan, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT02521103 about?
NCT02521103 is a clinical study titled "Triathlon Tritanium Cone Augments Outcomes Study". This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The re...
What is the current status of trial NCT02521103?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 145 participants. The study started on 2015-08. Estimated completion is 2028-03-31.
What conditions does trial NCT02521103 study?
This clinical trial studies the following conditions: Arthroplasty, Replacement, Knee.
What interventions are being tested in trial NCT02521103?
The interventions under investigation include: Triathlon Tritanium Cone Augments (DEVICE).
Who is sponsoring clinical trial NCT02521103?
This trial is sponsored by Stryker Orthopaedics, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02521103 being conducted?
This trial has 9 study locations across Florida, Illinois, Kentucky, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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