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

The University of Texas System (UT)

Status: Withdrawn

Conditions: Knee Arthritis

Treatments: Procedure: manually instrumented total knee arthroplasty; Device: robotic assisted total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03052790

HSC-MS-16-1096

Details and patient eligibility

About

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.

Sex: All

Ages: 25 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have knee pain and are candidates for total knee arthroplasty
• Patients able to consent to be included in the study

Exclusion criteria

• Patients with previous total or partial knee arthroplasty in need of revision surgery
• Patients unable to or unwilling to undergo post-operative CT scans after understanding the risks and benefits

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

manually instrumented total knee arthroplasty

Active Comparator group

Description:

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.

Treatment:

Procedure: manually instrumented total knee arthroplasty

robotic assisted total knee arthroplasty

Experimental group

Description:

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.

Treatment:

Device: robotic assisted total knee arthroplasty