Status:

TERMINATED

Evaluate the Performance of JOURNEY II CR in TKA Populations

Lead Sponsor:

Smith & Nephew, Inc.

Conditions:

Arthroplasty

Replacement

Eligibility:

All Genders

18-80 years

Brief 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 Ob...

Eligibility Criteria

Inclusion

  • 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

  • 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 to become pregnant during the follow up.
  • Subject does not meet the indication or is contraindicated for JOURNEY II CR's IFU.

Key Trial Info

Start Date :

March 3 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 15 2024

Estimated Enrollment :

62 Patients enrolled

Trial Details

Trial ID

NCT04818840

Start Date

March 3 2022

End Date

March 15 2024

Last Update

August 20 2025

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Peking University Third Hospital

Beijing, China, 100083

2

Prince of Wales Hospital

Hong Kong, China

3

Aster RV Hospital, Bangalore

Bengaluru, Karnataka, India, 560078

4

Arcus Hospital

Pune, Maharashtra, India, 411040