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Completed

NCT Number: NCT05107414

Journey 2 Multi Center Kinematic Study

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Tennessee

Knoxville, Tennessee, 37996, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.
  • Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.
  • Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
  • Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability
  • Subjects who are unable to perform a deep knee bend.
  • Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
  • Subjects without the required type of knee implant.

Treatment and study plan

Total knee arthroplasty

Device

Participants have previously undergone a total knee replacement surgery.

Other names: Smith & Nephew Journey II TKA

Primary outcomes

  1. Femorotibial Medial Condylar Rollback

    Time frame: Baseline, at time of observation

    The condylar rollback of the medial condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm].

  2. Femorotibial Lateral Condylar Rollback

    Time frame: Baseline, at time of observation

    The condylar rollback of the lateral condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm].

  3. Femorotibial Axial Rotation

    Time frame: Baseline, at time of observation

    The femorotibial axial rotation will be observed at a single instance in time. Higher rotation indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg].

  4. Femorotibial Weight Bearing Flexion

    Time frame: Baseline, at time of observation

    The femorotibial weight bearing flexion will be observed at a single instance in time. Higher flexion indicates greater range of motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg].

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Registry information

Official study title

Multi-center In Vivo Kinematics for Subjects Implanted With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 4, 2021
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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