NCT02380092

Post Market Clinical Follow Up of LEGION™ Primary TKS With VERILAST™

A Multicentre, Prospective, Post Market Clinical Follow Up Study of the LEGION™ Primary Total Knee System With VERILAST™ Bearing Surface

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 163 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™ bearing surface (OXINIUM™ femoral component with highly cross-linked polyethylene tibial insert). All study subjects will receive a LEGION™ Primary Total Knee System with VERILAST™ bearing surface and the results will be analysed against historical data from patients who received a Genesis II knee replacement.

Detailed description

The LEGION™ Primary Total Knee System (TKS) is a comprehensive, state-of-the-art system that empowers surgeons to address diverse surgical challenges and provide personalized joint care. The LEGION™ Primary TKS implant designs were built on the legacy of the GENESIS™ II TKS. For more than 15 years and in more than 30 countries, the GENESIS™ II TKS has achieved outstanding clinical outcomes. As CE-mark and 510k approval for the LEGION™ Primary TKS has been obtained, it is being used in clinical practice in several countries including Europe and the US but clinical studies need to be carried out in order to confirm its safety and efficacy and in order to conform to the medical device directives (MEDDEV. 2.7.1 Rev.3). This study is therefore a post-market study to evaluate the short-, mid- and long-term safety and effectiveness of the LEGION™ Primary TKS with VERILAST™ bearing surface (the combination of an OXINIUM™ femoral component with highly cross-linked polyethylene tibial base plate inserts). The clinical outcome from a large cohort of subjects who are treated with the LEGION™ Primary TKS as part of their standard of care will be documented. The study is designed to reflect standard clinical practice as closely as possible because it allows the results of such a study to represent the true clinical outcome that would be achieved in clinical practice, up to a maximum. Only subjects who will be treated with the LEGION™ Primary TKS as part of their normally planned care will screened for participation in this study.

Conditions

• Degenerative Joint Disease

Interventions

Type	Name	Description
DEVICE	LEGION™ Primary TKS with VERILAST™ Bearing Surface	All study subjects will be treated with LEGION™ Primary TKS with VERILAST™ Bearing Surface as per standard clinical practice.

Timeline

• Start date: 2015-09-01
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2015-03-05
• Last updated: 2025-12-15

Locations

7 sites across 3 countries: Austria, Germany, Spain