Robotic Assisted TKA

Study Overview
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Brief Summary
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As an intraoperative tool, a modern robotic total knee arthroplasty (TKA) system should be able to identify a patient's native femoral and tibial anatomy, as well as, assess ligament tension and gap balance. The surgeon in real time is then able to develop and execute a patient specific plan in terms of component size, alignment and rotation. In our institution we have begun to use, the OMNIBotics Knee system (Corin), which utilizes an active motorized knee spacer, BalanceBot, to objectively measure ligament tension and gap balance after the tibia has been cut and its alignment confirmed. This information is then processed through the OMNIbotics computer algorithm to appropriately size, align, and rotate the femur component to balance the flexion and extension gaps. The purpose of this study is to perform a randomized pilot study looking for an effect on early functional outcomes comparing robotic assisted TKA (RATKA) versus conventional TKA technique.

Official Title
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Randomized Pilot Study Investigating Early Functional Outcomes With the Use of Robotic Assisted Versus Conventional Total Knee Arthroplasty

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Procedure: Total knee replacement using Omnibot Knee System
* Procedure: Conventional Total knee replacement
* Device: Omnibot Robotic Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All unilateral primary knee arthroplasties performed by the investigator participating in this study will be eligible for inclusion Diagnosis of primary osteoarthritis Exclusion Criteria: Revision surgery Bilateral knee surgery Age <18 or >80 BMI >40 Baseline lower extremity strength less than 5/5 History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours Functionally limiting spine disease Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease) Patients who cannot perform the baseline functional tests Allergy/contraindication to protocol medications Post-traumatic arthritis Inflammatory arthritis Pregnancy Prisoners Patients receiving care as a result of a worker's compensable injury General anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total knee replacement (TKR) without Omnibot system<br>The participant will undergo TKR utilizing conventional techniques. | Procedure: Conventional Total knee replacement<br>* Conventional total knee replacement without robotic assistance<br>|
| Active Comparator: Total knee replacement (TKR) with Omnibot<br>The participant will undergo a robotic assisted TKR utilizing the Omnibot Knee System | Procedure: Total knee replacement using Omnibot Knee System<br>* total knee replacement with robotic assistance<br>Device: Omnibot Robotic Knee System<br>* utilizes an active motorized knee spacer to measure ligament tension and gap balance after the tibia has been cut during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early functional outcomes #1 | This will be measured by the timed-up-and-go test. | 6 months | 
| Early functional outcomes #2 | This will be measured by the stair climbing test. | 6 months |