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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02058069
Study type Interventional
Source MAKO Surgical Corp.
Contact
Status Completed
Phase N/A
Start date February 2014
Completion date January 2015

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