Multi-center In Vivo Kinematics for Subjects Implanted With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Total Knee Arthroplasty
- Sponsor
- The University of Tennessee, Knoxville
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Femorotibial Medial Condylar Rollback
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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. 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 \[deg\].