CompletedNot Applicable

Journey 2 Multi Center Kinematic Study

United States201 participantsStarted 2021-05-15

Plain-language summary

The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.

Who can participate

Age range

18 Years – 85 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

. Patients in the age range of 18 years to 85 years (both inclusive)
. Patients who have a BMI less than 35
. Patients who do not have previous surgery on the implanted knee that might restrict their movement
. Patient who are at least 6 months post-operative
. Patients who do not experience any pain or other post-operative complications
. Patients who have a stable TKA and can perform a deep knee bend activity
. Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms
. Subjects will have a Journey II knee system

Exclusion criteria

. Pregnant, potentially pregnant, or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
. Patients who have currently enrolled in a fluoroscopic study within the past year.

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

Femorotibial Medial Condylar Rollback

Timeframe: Baseline, at time of observation

Femorotibial Lateral Condylar Rollback

Timeframe: Baseline, at time of observation

Femorotibial Axial Rotation

Timeframe: Baseline, at time of observation

Femorotibial Weight Bearing Flexion

Timeframe: Baseline, at time of observation

Trial details

NCT IDNCT05107414

SponsorThe University of Tennessee, Knoxville

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

Results submitted2026-04-29

View on ClinicalTrials.gov More Total Knee Arthroplasty trials

Who can participate

Age range

18 Years – 85 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

. Patients in the age range of 18 years to 85 years (both inclusive)
. Patients who have a BMI less than 35
. Patients who do not have previous surgery on the implanted knee that might restrict their movement
. Patient who are at least 6 months post-operative
. Patients who do not experience any pain or other post-operative complications
. Patients who have a stable TKA and can perform a deep knee bend activity
. Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms
. Subjects will have a Journey II knee system

Exclusion criteria

. Pregnant, potentially pregnant, or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
. Patients who have currently enrolled in a fluoroscopic study within the past year.

What they're measuring

Femorotibial Medial Condylar Rollback

Timeframe: Baseline, at time of observation

Femorotibial Lateral Condylar Rollback

Timeframe: Baseline, at time of observation

Femorotibial Axial Rotation

Timeframe: Baseline, at time of observation

Femorotibial Weight Bearing Flexion

Timeframe: Baseline, at time of observation