At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
In Vivo Comparison of Kinematics for Subjects Implanted With a Press Fit Condylar Sigma Rotating Platform or Fixed Bearing Total Condylar III Prothesis
In Brief
An observational study evaluating DePuy fixed-bearing Total Condylar III (TC3) TKA and DePuy PFC Rotating Platform TC3 TKA for Knee Prosthesis and Knee Arthroplasty. Completed, enrolled 22 participants across 3 sites.
Detailed Summary
The objectives of this study are four-fold: 1. To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing the in vivo kinematics to determine if one implant type leads to a benefit for the patient. 2. To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar III Prosthesis under in vivo, weight-bearing conditions during multiple activities (gait, stair descent, deep knee bend and chair rise). 3. To determine if there is a correlation between in vivo kinematic data obtained using fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine if variability occurs between these two TKA types. 4. To determine if a clinical benefit is either visibly detected (video camera) or quantifiably determined (questionnaire) for either TKA type.