Rheumatoid Arthritis Clinical Trial
Official title:
Robotic Arm Assisted Total Knee Arthroplasty
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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