Active — Not RecruitingNot Applicable

JOURNEY™ II CR Total Knee System

United States, Spain, United Kingdom170 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 range

22 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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