Total Knee Anthroplasty Clinical Trial
Official title:
Kinematics Analysis: Comparison Between the Cruciate Retaining, Fixed Bearing Primary Total Knee Arthroplasty ATTUNE TM Knee System and the Fixed Bearing PFC Sigma Curved Total Knee Arthroplasty
| Verified date | December 2019 |
| Source | Institute for Biomechanics, ETH Zürich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The primary objective is to quantify and compare the three-dimensional kinematics of the
cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved
CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily activities.
The secondary objective is to describe the kinematics in terms of range of motion, patterns
of anterior-posterior motion of the nearest medial and lateral points ("posterior femoral
rollback") and tibio-femoral internal/external rotation as well as the kinetics during daily
activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto
a chair, standing up from a chair and stair descent by means of video-fluoroscopy.
Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and
to the Center for Orthopaedic Engineering of the University of Denver, where it will be used
within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and
changes in the musculoskeletal system due to the TKA.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Unilateral TKA (ATTUNETM/Sigma) due to osteoarthritis - BMI = 33 - Good clinical outcome, KOOS > 70 - No or very low pain VAS < 2 - At least one year post-op - Standardized general health survey score (SF-12) within the normal range for people in their age group Exclusion Criteria: - Actual significant problem on lower extremities - Misaligned TKA - Any other arthroplasty at the lower extremities - Patient incapable to understand and sign informed consent - Incapable of performing the motion tasks - Pregnancy |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Institute for Biomechanics, ETH Zurich | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| Dr. Renate List |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparison of the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA | With video-fluoroscopic assessment it is possible to directly measure the kinematics of the tibial and the femoral components in vivo during daily activities, such as level walking, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the ATTUNETM System during daily activities and allows a comparison to a conventional TKA based on the same methodology. The knowledge of the in vivo kinematic behaviour of the ATTUNETM System in comparison to the conventional TKA leads to an improved understanding of the design principle. | 3 hours |