LEGION™ Primary Safety and Efficacy
NCT04040985 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2024-10-10
Summary
This study will look at the health results of using the LEGION™ Primary Knee System over a period of ten (10) years. This type of surgery uses an artificial knee made of plastic and metal. This study will enter subjects who suffer from a variety of conditions that have caused at least one of their knees to become nonfunctional. You are being asked to participate in the study because you have significant problems with your knee(s) and your study surgeon has determined that your knee(s) must be surgically replaced to improve your condition. If you decided to participate in this study, you will be one of approximately one hundred thirty-eight (138) subjects in the study.
Conditions
- Osteo Arthritis Knee
- Total Knee Replacement
Interventions
- PROCEDURE
-
Total Knee Arthroplasty using LEGION™ Total Knee System
Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Sponsors & Collaborators
-
Smith & Nephew, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-09
- Primary Completion
- 2020-12-17
- Completion
- 2020-12-17
Countries
- United States
Study Locations
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