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

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Arthritis

Intervention / Treatment
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* Procedure: manually instrumented total knee arthroplasty
* Device: robotic assisted total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: manually instrumented total knee arthroplasty<br>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<br>* 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.<br>|
| Experimental: robotic assisted total knee arthroplasty<br>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<br>* 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.<br>|

What is the study measuring?
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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 |