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NCT02445443 · ClinicalTrials.gov registry record
LEGION Hinge Safety and Efficacy Study
A clinical trial of Knee Arthroplasty, Total, sponsored by Smith & Nephew.
- Active
- Registry status
- 47
- Enrollment target
- 7
- Study locations
NCT02445443: Active study of Knee Arthroplasty, Total, sponsored by Smith & Nephew.
NCT02445443 is a study of Knee Arthroplasty, Total that is active but no longer recruiting, run by Smith & Nephew. The registered enrollment target is 47 participants, below the 1,903-participant average among 3 other Knee Arthroplasty, Total trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02445443, a study of Knee Arthroplasty, Total, is active but no longer recruiting, sponsored by Smith & Nephew.
- ACTIVE NOT RECRUITING
- Registry status
- 47 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).
Primary Outcome
The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The KSCS will be administered at the pre-operative visit and all follow-up visits. The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years.
Conditions Studied
Interventions
- DEVICE LEGION Hinge Knee System
Study Locations (7)
Iowa
- University of Iowa Hospitals - Iowa City
New York
- NYU Hospital for Joint Diseases - New York
Oregon
- Oregon Health and Science University - Portland
Western Australia
- Fremantle Hospital - Fremantle
Other
- UZ Leuven campus Pellenberg - Pellenberg
Manitoba
- Concordia Hip and Knee Institute - Winnipeg
Barcelona
- University Hospital Mutua de Terrassa - Terrassa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2015-06-30 |
| Est. Completion | 2028-08-01 |
What the registry record for NCT02445443 still lists
NCT02445443 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,903-participant average among 3 other Knee Arthroplasty, Total trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Knee Arthroplasty, Total appearing as the primary indexed condition, and to 1 intervention - of which LEGION Hinge Knee System is the first listed.
NCT02445443 lists 7 locations in 7 states (Iowa, New York, Oregon).
Frequently Asked Questions
What is clinical trial NCT02445443 about?
NCT02445443 is a clinical study titled "LEGION Hinge Safety and Efficacy Study". The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly ...
What is the current status of trial NCT02445443?
This trial is currently active not recruiting. The enrollment target is 47 participants. The study started on 2015-06-30. Estimated completion is 2028-08-01.
What conditions does trial NCT02445443 study?
This clinical trial studies the following conditions: Knee Arthroplasty, Total.
What interventions are being tested in trial NCT02445443?
The interventions under investigation include: LEGION Hinge Knee System (DEVICE).
Who is sponsoring clinical trial NCT02445443?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02445443 being conducted?
This trial has 7 study locations across Iowa, New York, Oregon, Western Australia, Manitoba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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