Active — Not RecruitingNot Applicable

JOURNEY™ II CR Total Knee System

United States170 participantsStarted 2015-09

Plain-language summary

The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.

Who can participate

Age range22 Years – 75 Years

SexALL

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Inclusion criteria

✓. Has signed the IRB/EC approved ICF specific to this study prior to study participation
✓. Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee
✓. Is a candidate for primary total knee arthroplasty with the JOURNEY™ II CR Total Knee System due to DJD, defined by one of the following:
✓. Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral)
✓. Is in general good health (as determined by the Investigator) based on screening assessments and medical history
✓. Is independent, ambulatory, and can comply with all post-operative evaluations
✓. plans to be available through ten (10) years post-operative follow-up

What they're measuring

Equivalence in 1 year post-operative mean Range of Motion (ROM) in subjects receiving the J II CR TKS as compared to the literature reference mean ROM

Timeframe: 1 year post-op analysis

Non-inferiority of the survival rate of the J II CR TKS with the reference survival rate of a literature reference at 5 and 10-years post-operatively

Timeframe: Up to 10 year post-operative analysis

Trial details

NCT IDNCT02440672

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-06

View on ClinicalTrials.gov More Osteoarthritis, Knee trials