NCT03052790

Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 25 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the outcomes and accuracy of implant positioning in robotic assisted total knee arthroplasty with traditional manually instrumented total knee arthroplasty.

Conditions

• Knee Arthritis

Interventions

Type	Name	Description
PROCEDURE	manually instrumented total knee arthroplasty	Manually instrumented implantation of a total knee prosthesis involves use of cutting guides or jigs that are secured to the femur and the tibia. The femoral guide is secured to the femur after an intramedullary referenced guide is placed into the femur and the rotational alignment is then assessed with use of the epicondylar axis. An extra-medullary tibial alignment guide will be used to create the tibial cut.
DEVICE	robotic assisted total knee arthroplasty	Robotically assisted surgery is used in conjunction with the preoperative CT scan and intra-operative bony registration of the patient's knee. Femoral and tibial trackers are placed and then the bone is registered using bony landmarks to allow the computer and robot to know where the patients' femur and tibia are in space. Once this is complete the preoperative templated surgical plan (performed by the PI) is used to register where to make the bony cuts in order to implant the knee components. The cutting process is performed by the surgeon with the robot assisting in guiding the cuts based on the registered CT anatomy. The surgeon has complete control of the cutting process with the assistance of the robot for placement of the cuts.

Timeline

• Start date: 2018-07-01
• Primary completion: 2019-07-01
• Completion: 2019-12-01
• First posted: 2017-02-14
• Last updated: 2019-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study