Status:
TERMINATED
LEGION™ Primary Safety and Efficacy
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Osteo Arthritis Knee
Total Knee Replacement
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
This is a prospective, consecutive series, multi-center clinical study of the LEGION™ Total Knee System. The study design was selected to assess the safety and effectiveness profile of the LEGION™ Tot...
Eligibility Criteria
Inclusion
- Subjects must meet all of the inclusion criteria:
- Subject is a candidate for the LEGION™ Primary Knee System according to the instructions for use
- Subject is of legal age and skeletally mature
- Subject is willing to sign and date an ethics-approved consent form and participate in the study
- Subject is willing to be available for ten-year follow-up postoperatively.
Exclusion
- Subjects must not meet any of the exclusion criteria:
- Subject with immunosuppressive disorders
- Subject has grossly insufficient femoral or tibial bone stock
- Subject has an active localized or systemic infection
- Subject is pregnant
- Subject psychological or neurological conditions that would impair the subject's ability or willingness to restrict activities or follow medical advice during the course of this study
- Subject is a prisoner.
Key Trial Info
Start Date :
September 9 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2020
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04040985
Start Date
September 9 2009
End Date
December 17 2020
Last Update
October 10 2024
Active Locations (5)
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1
Orthopaedic Associates of Vero Beach
Vero Beach, Florida, United States, 32960
2
Iowa Orthopaedic Center
Des Moines, Iowa, United States, 50314
3
Louisville Bone & Joint Specialist, PSC
Louisville, Kentucky, United States, 40207
4
University Hip and Knee Specialists
Monroe, New Jersey, United States, 08831