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

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 Overview

• Status: Withdrawn
• Conditions: Knee Arthritis
• Intervention / Treatment: Procedure: manually instrumented total knee arthroplasty; Device: robotic assisted total knee arthroplasty

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 70043
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 2 weeks before surgery, within one month of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as assessed by the PROMIS 10 measurement system	Patient-Reported Outcomes Measurement Information System (PROMIS)	within 2 weeks before surgery
Pain as assessed by the PROMIS 10 measurement system	Patient-Reported Outcomes Measurement Information System (PROMIS)	3 months after surgery
Pain as assessed by the PROMIS 10 measurement system	Patient-Reported Outcomes Measurement Information System (PROMIS)	6 months after surgery
Pain as assessed by the PROMIS 10 measurement system	Patient-Reported Outcomes Measurement Information System (PROMIS)	1 year after surgery
Function as assessed by the PROMIS 10 measurement system		within 2 weeks before surgery
Function as assessed by the PROMIS 10 measurement system		3 months after surgery
Function as assessed by the PROMIS 10 measurement system		6 months after surgery
Function as assessed by the PROMIS 10 measurement system		1 year after surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system		within 2 weeks before surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system		3 months after surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system		6 months after surgery
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)	Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.	within 2 weeks before surgery
Pain as assessed by a Visual Analogue Scale (VAS)	Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.	3 months after surgery
Pain as assessed by a Visual Analogue Scale (VAS)	Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.	6 months after surgery
Pain as assessed by a Visual Analogue Scale (VAS)	Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.	1 year after surgery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Adam Freedhand, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (ACTUAL): February 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: HSC-MS-16-1096

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No