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

Not Applicable

Withdrawn

• Conditions: Knee Arthritis
• Interventions: Procedure: manually instrumented total knee arthroplasty; Device: robotic assisted total knee arthroplasty

• Registration Number: NCT03052790
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Study Start: 2018-07-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04
• Primary Completion: 2019-07-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manually instrumented total knee arthroplasty	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.
robotic assisted total knee arthroplasty	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.

Primary Outcome Measures

Name	Time	Method
Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)	within 2 weeks before surgery, within one month of surgery	The absolute value of the individual differences in various angle measurements will be added together to form a total summation of angle difference.

Secondary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system	1 year after surgery
Pain as assessed by a Visual Analogue Scale (VAS)	1 year after surgery	Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.
Function as assessed by the PROMIS 10 measurement system	1 year after surgery
Pain as assessed by the PROMIS 10 measurement system	1 year after surgery	Patient-Reported Outcomes Measurement Information System (PROMIS)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States