Evaluate the Performance of JOURNEY II CR in TKA Populations

Last updated: August 26, 2024
Sponsor: Smith & Nephew, Inc.
Overall Status: Terminated

Phase

N/A

Condition

Orthopedics

Treatment

Un-resurfaced Patella

Resurfaced Patella

Clinical Study ID

NCT04818840
Journey II CR.2020.11
  • Ages 18-80
  • All Genders

Study Summary

Background:

The JOURNEY II CR Total Knee System consists of femoral component made from oxidized zirconium (OXINIUM)

Purpose:

Post-market evidence generation for JOURNEY II CR Total Knee System

Objectives:

Evaluate the performance of JOURNEY II CR TKA in APAC populations Evaluate the impact of patella resurfacing on the outcomes of JOURNEY II CR TKA

Research participants / locations:

A total of up to 480 knees' information will be collected in up to 15 sites in India, China mainland, Hong Kong, Singapore, Thailand and Japan There will be up to 240 knees for resurfaced patella group and up to 240 knees for un-resurfaced patella group.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with degenerative osteoarthritis.

  • Subject is planning to have TKA using JOURNEY II CR.

  • Subject is able and willing to provide voluntary consent to study participation.

  • Subject is 18-80 years old (inclusive) * (* For Japan, the minimum inclusion age is 20 years old.)

Exclusion

Exclusion Criteria:

  • Subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis.

  • Previous surgeries including HTO, UKA or TKA on the subject knee.

  • Subject is pregnant or breast feeding or those at a child-bearing age planning tobecome pregnant during the follow up.

  • Subject does not meet the indication or is contraindicated for JOURNEY II CR's IFU.

Study Design

Total Participants: 53
Treatment Group(s): 2
Primary Treatment: Un-resurfaced Patella
Phase:
Study Start date:
March 03, 2022
Estimated Completion Date:
March 15, 2024

Connect with a study center

  • Peking University Third Hospital

    Beijing, 100083
    China

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong,
    China

    Site Not Available

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, 200001
    China

    Site Not Available

  • Medanta Institute of Muscloskeletal Diseases, and Orthopaedics

    Gurgaon, Haryana 122001
    India

    Site Not Available

  • Aster RV Hospital, Bangalore

    Bengaluru, Karnataka 560078
    India

    Site Not Available

  • Arcus Hospital

    Pune, Maharashtra 411040
    India

    Site Not Available

  • Toho University Omori Medical Center

    Tokyo, 1438540
    Japan

    Site Not Available

  • Tokyo Women's Medical University

    Tokyo, 1628666
    Japan

    Site Not Available

  • Singapore General Hospital

    Singapore, 169608
    Singapore

    Site Not Available

  • Chulalongkorn Hospital

    Bangkok, 10330
    Thailand

    Site Not Available

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