Trials / Active Not Recruiting
Active Not RecruitingNCT02445443
LEGION Hinge Safety and Efficacy Study
A Prospective, Multi-center Clinical Study Evaluating the LEGION™ Hinge Knee System
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 47 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
The objective of this study is to demonstrate statistically significant improvements in the original Knee Society Clinical Score (KSCS) from baseline to 1 and 2 years in subjects using the LEGION™ Hinge Knee System. The focus of the 1 and 2 year analyses will be on safety and efficacy. The 5 year analysis will focus on survivorship and safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LEGION Hinge Knee System | All enrolled/treated subjects will receive the LEGION Hinge Knee System. |
Timeline
- Start date
- 2015-06-30
- Primary completion
- 2027-12-31
- Completion
- 2028-08-01
- First posted
- 2015-05-15
- Last updated
- 2024-11-27
Locations
7 sites across 5 countries: United States, Australia, Belgium, Canada, Spain
Source: ClinicalTrials.gov record NCT02445443. Inclusion in this directory is not an endorsement.