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

The University of Texas Health Science Center, Houston

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Knee Arthritis

Interventions

manually instrumented total knee arthroplastyPROCEDURE

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.

robotic assisted total knee arthroplastyDEVICE

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)

The absolute value of the individual differences in various angle measurements will be added together to form a total summation of angle difference.

Time frame: within 2 weeks before surgery, within one month of surgery

Secondary Outcomes

Pain as assessed by the PROMIS 10 measurement system

Patient-Reported Outcomes Measurement Information System (PROMIS)

Time frame: within 2 weeks before surgery

Pain as assessed by the PROMIS 10 measurement system

Patient-Reported Outcomes Measurement Information System (PROMIS)

Time frame: 3 months after surgery

Pain as assessed by the PROMIS 10 measurement system

Patient-Reported Outcomes Measurement Information System (PROMIS)

Time frame: 6 months after surgery

Pain as assessed by the PROMIS 10 measurement system

Patient-Reported Outcomes Measurement Information System (PROMIS)

Time frame: 1 year after surgery

Function as assessed by the PROMIS 10 measurement system

Time frame: within 2 weeks before surgery

Function as assessed by the PROMIS 10 measurement system

Time frame: 3 months after surgery

Function as assessed by the PROMIS 10 measurement system

Time frame: 6 months after surgery

Data from ClinicalTrials.gov

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