joint replacement total knee replacement
Conditions
Interventions
None listed
Sponsors
Orthopaedic Innovation Technology Center
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects will have the appropriate TKA system: a Smith & Nephew Journey II BCS TKA. 2. Patients in the age range of 18 years to 85 years (both inclusive) 3. Patients who do not have previous surgery on either knee that might restrict their movement 4. Patient who are at least 6 months post-operative 5. Patients will be less than 11 years post-operative. 6. Patients who can perform the requested activity safely 7. Patients who are willing to participate in this study and are willing to sign appropriate informed consent forms
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant, trying to become pregnant, or lactating. 2. Patients who have enrolled in a fluoroscopic kinematic study within the past year. 3. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The weight-bearing kinematics will be assessed using traditional 3D-to-2D registration techniques. Raw data consists of the fluoroscopy video, and using registration techniques, we are able to extract the 3D position of the components and then analyze various parameters-of-interest, such as medial condyle contact position. Specific femorotibial parameters of interest will include maximum flexion, anterior/posterior motion of the medial and lateral condyles, axial rotation throughout each activity, and cam/post engagement angles (if applicable). In other words, researchers will determine the relative motion of the femoral component atop the tibial component as patients flex their knee. Patellofemoral kinematics will include in vivo patellofemoral contact pattern in the sagittal plane, in vivo patellar tilt in the sagittal plane with respect to tibia bone, patellofemoral separation, and patella ligament rotation in the sagittal plane. All parameters of interest will be measured directly from the fluoroscopy images. | — |
Secondary
| Measure | Time frame |
|---|---|
| VAG signals will be correlated to cam-post engagement times. Specifically, when the posterior cam/post engage (determined from the fluoroscopy overlays), we will observe the filtered VAG signals to determine if there is a spike in the signal data. Additionally, signals will be evaluated for noisy versus quiet signals, based on signal amplitude, and this will be correlated to weight-bearing kinematics as well as outcome scores. Patient-reported Outcome Measures will be collected by the Forgotten Joint Score, the Oxford Knee Score, KOOS-PS, NRS for pain and satisfaction. All surveys have been previously validated. Functional outcome parameters will be assessed by two mobility tasks, including gait and sit-to-stand transfers. Specifically, patients will walk for 2 minutes back and forth a 10m trajectory making 180* turns. This task will be repeated while performing a secondary, cognitive task to evaluate the level of attention they need for this task. Subsequently, the participants will be instructed to rise from a chair at their comfortable speed. During these tasks, inertial measurement units will be used to record the tasks and obtain spatiotemporal outcome measures. | — |
Countries
Netherlands
Outcome results
None listed