In Vivo Kinematics for Subjects With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
Multi-center In Vivo Kinematics for Subjects Implanted With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2020
CompletedFirst Submitted
Initial submission to the registry
October 27, 2020
CompletedFirst Posted
Study publicly available on registry
November 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2022
CompletedResults Posted
Study results publicly available
November 29, 2023
CompletedNovember 29, 2023
February 1, 2023
1.6 years
October 27, 2020
May 17, 2022
February 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Medial AP Translations, in mm
Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.
At least 6 months postoperative
Lateral AP Translations, in mm
Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.
At least 6 months postoperative
Maximum Flexion, in Degrees
Maximum weight-bearing flexion, in degrees, during Deep Knee Bend Activity. Maximum flexion indicated how far a participant can bend their knee during a DKB. A larger number indicates greater flexion, i.e. more bending.
At least 6 months postoperative
Axial Rotation, in Degrees
Axial Rotation, in degrees, during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their squat activity. A positive number indicates external femorotibial axial rotation from full extension to maximum flexion, and a negative number indicates internal femorotibial axial rotation from full extension to maximum flexion.
At least 6 months postoperative
Study Arms (3)
Journey II Bi-Cruciate Stabilized
Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected
Journey II Cruciate Retaining
Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained)
Journey II Bi-Cruciate Retaining
Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained
Interventions
Total Knee Arthroplasty System
Total Knee Arthroplasty System
Eligibility Criteria
Patients with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs
You may qualify if:
- 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, either the BCS or XR, knee system
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Tennessee
Knoxville, Tennessee, 37996, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael LaCour
- Organization
- University of Tennessee
Study Officials
- PRINCIPAL INVESTIGATOR
Michael LaCour, PhD
The University of Tennessee
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2020
First Posted
November 2, 2020
Study Start
October 22, 2020
Primary Completion
May 16, 2022
Study Completion
May 16, 2022
Last Updated
November 29, 2023
Results First Posted
November 29, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share
Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.