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JOURNEY II XR Safety and Effectiveness PMCF

NCT03136887 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 176

Last updated 2024-08-12

No results posted yet for this study

Summary

This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.

Conditions

  • Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee
  • Unilateral Post-Traumatic Osteoarthritis of Knee
  • Knee Osteoarthritis
  • Degenerative Arthritis Peripheral Joint
  • Failed Osteotomies
  • Failed Unicompartmental Replacement

Interventions

DEVICE

JOURNEY II XR Total Knee System

JOURNEY II XR Total Knee System

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-28
Primary Completion
2029-04-30
Completion
2029-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03136887 on ClinicalTrials.gov