NCT02412813

LEGION™ Revision Metal Hypersensitivity Study

A Prospective, Randomized, Multi-Center, Metal Hypersensitivity Study Comparing OXINIUM and Cobalt Chrome Femoral Components in Failed Total Knee Arthroplasty

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA).

Detailed description

A total of 230 subjects will be randomized (1:1) to receive either an OXINIUM or cobalt chrome femoral components as part of their LEGION revision procedure. The objective of this study is to assess a lower serum metal ion concentration level in at least one of the three major mLTTs (Co, Cr or Ni) over 5 years in subjects receiving OXINIUM versus Cobalt Chrome femoral components as part of the LEGION Revision Total Knee System.

Conditions

• Total Knee Replacement Revision

Interventions

Type	Name	Description
DEVICE	LEGION OXINIUM	Investigational Group
DEVICE	LEGION Cobalt Chrome	Control Group

Timeline

• Start date: 2016-01-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2015-04-09
• Last updated: 2016-03-09

Locations

3 sites across 2 countries: United States, Canada