NCT02058069

Robotic Arm Assisted Total Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: MAKO Surgical Corp. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Post-traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	Robotic Arm Assisted Total Knee Arthroplasty	The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-02-07
• Last updated: 2017-04-18
• Results posted: 2016-02-12

Locations

3 sites across 1 country: United States