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LEGION™ Revision Metal Hypersensitivity Study

NCT02412813 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-03-09

No results posted yet for this study

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).

Conditions

  • Total Knee Replacement Revision

Interventions

DEVICE

LEGION OXINIUM

Investigational Group

DEVICE

LEGION Cobalt Chrome

Control Group

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Turgeon, MD · Orthopaedic Innovation Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02412813 on ClinicalTrials.gov