In Vivo Kinematics for Subjects Implanted With Klassic Total Knee Arthroplasty (TKA) (TKA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04113785|
Recruitment Status : Completed
First Posted : October 3, 2019
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment|
|Total Knee Arthroplasty Osteo Arthritis Knee Knee Implant Knee Injuries||Device: Klassic Knee System|
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||In Vivo Kinematics for Subjects Implanted With Klassic TKA|
|Actual Study Start Date :||October 1, 2018|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||June 5, 2019|
Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported.
Device: Klassic Knee System
At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee
- Axial Rotation (AR) During Deep Knee Bend [ Time Frame: at least 6 months post-operative ]Rotation of femoral component with respect to tibial component during deep knee bend. Positive indicated external rotation of femur wrt tibia.
- Maximum Weight-bearing Flexion During Deep Knee Bend [ Time Frame: at least 6 months post-operative ]Maximum weight-bearing flexion that the subjects are able to achieve during deep knee bend. All values are positive.
- Medial Condyle Translations During Deep Knee Bend Activity. [ Time Frame: at least 6 months post-operative ]Anterior Posterior (AP) translations of medial femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.
- Lateral Condyle Translations During Deep Knee Bend Activity [ Time Frame: at least 6 months post-operative ]Anterior Posterior (AP) translations of lateral femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113785
|United States, Utah|
|Hofmann Arthritis Institute for Precision Joint Replacement|
|Salt Lake City, Utah, United States, 84102|
|Principal Investigator:||Richard Komistek, Ph.D.||The University of Tennessee|