Finished
Robotic Arm Assisted Total Knee Arthroplasty
NCT02058069 · MAKO Surgical Corp. · Updated 18 April 2017
- What is being tested
- Robotic Arm Assisted Total Knee Arthroplasty
- For
- Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 21 years and older. About 100 people. The full rules are on the registry page.
- Where
- United States (3 sites)
- When
- Starts or started Feb 2014, ends Jan 2015. Registered 7 Feb 2014.
- Results
- Posted on the registry on 12 Feb 2016.
In the researchers' words
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.
Sites
- Coon Joint Replacement Institue; St. Helena HospitalSt. Helena, California, United States
- Florida Orthopedic InstituteTampa, Florida, United States
- Memorial Bone and Joint Research Foundation; Memorial Hermann Memorial City Medical CenterHouston, Texas, United States