Total Knee Arthroplasty
Conditions
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.
Interventions
DEVICETotal Knee Arthroplasty
Participants have previously undergone a total knee replacement surgery.
Sponsors
The University of Tennessee, Knoxville
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. 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 \[mm\]. |
| 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. 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 \[mm\]. |
| Femorotibial Axial Rotation | 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 \[deg\]. |
| Femorotibial Weight Bearing Flexion | 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 \[deg\]. |
Countries
United States
Participant flow
Recruitment details
Subjects recruited from surgeon's previously implanted population
Pre-assignment details
One knee analyzed per participant
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 8.7 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 71 | 0 / 29 |
| other Total, other adverse events | 0 / 101 | 0 / 71 | 0 / 29 |
| serious Total, serious adverse events | 0 / 101 | 0 / 71 | 0 / 29 |
Outcome results
None listed