Journey 2 Multi Center Kinematic Study
- Conditions
- Total Knee Arthroplasty
- Interventions
- Procedure: Total Knee Arthroplasty
- Registration Number
- NCT05107414
- Lead Sponsor
- The University of Tennessee, Knoxville
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Journey II Bi-Cruciate Stabilized Total Knee Arthroplasty Participants who have been implanted with a Smith \& Nephew Journey II BCS TKA Journey II Cruciate Retaining Total Knee Arthroplasty Participants who have been implanted with a Smith \& Nephew Journey II CR TKA Journey II Bi-Cruciate Retaining Total Knee Arthroplasty Participants who have been implanted with a Smith \& Nephew Journey II BCR TKA
- Primary Outcome Measures
Name Time Method 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 \[mm\].
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 \[mm\].
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 \[deg\].
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 \[deg\].
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Tennessee
🇺🇸Knoxville, Tennessee, United States