At a glance
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Robotic Arm Assisted Total Knee Arthroplasty
In Brief
A clinical study evaluating Robotic Arm Assisted Total Knee Arthroplasty for Osteoarthritis and 2 related conditions. Completed, enrolled 100 participants across 3 sites.
Detailed Summary
The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB). The overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application. Specifically, the study objectives are classified as follows: * Primary Objective: Surgeon assessment of standardized TKA complications both intra-operatively and at short term follow up. * Secondary Objective: Radiographic assessment of post-operative limb alignment. * Supporting Objective: Patient assessment of post-operative function and satisfaction.
Study Details
Timeline
Interventions
The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).