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Journey 2 Multi Center Kinematic Study

Sponsor
The University of Tennessee, Knoxville (Other)
Overall Status
Recruiting
CT.gov ID
NCT05107414
Collaborator
(none)
220
Enrollment
1
Location
20
Anticipated Duration (Months)
11
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Total Knee Arthroplasty

Study Design

Study Type:
Observational
Anticipated Enrollment :
220 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official 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
Actual Study Start Date :
May 15, 2021
Anticipated Primary Completion Date :
Jan 15, 2023
Anticipated Study Completion Date :
Jan 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Journey II Bi-Cruciate Stabilized

Participants who have been implanted with a Smith & Nephew Journey II BCS TKA

Procedure: Total Knee Arthroplasty
Participants have previously undergone a total knee replacement surgery.
Other Names:
  • Smith & Nephew Journey II TKA

    		•
    Journey II Cruciate Retaining

    Participants who have been implanted with a Smith & Nephew Journey II CR TKA

    Procedure: Total Knee Arthroplasty
    Participants have previously undergone a total knee replacement surgery.
    Other Names:
  • Smith & Nephew Journey II TKA

    		•
    Journey II Bi-Cruciate Retaining

    Participants who have been implanted with a Smith & Nephew Journey II BCR TKA

    Procedure: Total Knee Arthroplasty
    Participants have previously undergone a total knee replacement surgery.
    Other Names:
  • Smith & Nephew Journey II TKA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Femorotibial Medial Condylar Rollback [Baseline, at time of observation]

      The condylar rollback of the medial condyle will be observed at a single instance in time. 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 [Baseline, at time of observation]

      The condylar rollback of the lateral condyle will be observed at a single instance in time. 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 [Baseline, at time of observation]

      The femorotibial axial rotation will be observed at a single instance in time. 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 [Baseline, at time of observation]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Patients in the age range of 18 years to 85 years (both inclusive)

    2. Patients who have a BMI less than 35

    3. Patients who do not have previous surgery on the implanted knee that might restrict their movement

    4. Patient who are at least 6 months post-operative

    5. Patients who do not experience any pain or other post-operative complications

    6. Patients who have a stable TKA and can perform a deep knee bend activity

    7. Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms

    8. Subjects will have a Journey II knee system

    Exclusion Criteria:

    1. 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.

    2. Patients who have currently enrolled in a fluoroscopic study within the past year.

    3. Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.

    4. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.

    5. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability

    6. Subjects who are unable to perform a deep knee bend.

    7. Subjects who are unwilling to sign Informed Consent/ HIPAA documents.

    8. Subjects without the required type of knee implant.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Tennessee Knoxville Tennessee United States 37996

    Sponsors and Collaborators

    • The University of Tennessee, Knoxville

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Tennessee, Knoxville
    ClinicalTrials.gov Identifier:
    NCT05107414
    Other Study ID Numbers:
    • 20203268
    First Posted:
    Nov 4, 2021
    Last Update Posted:
    Nov 4, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes

    Study Results

    No Results Posted as of Nov 4, 2021