MAKO Total Knee Artroplasty

Study Overview
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Brief Summary
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The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Results of this study will be compared to those of a previously published cohort of patients from this institution who underwent TKA using non-robotic, manual instruments. MAKO TKA patients will be given Fitbits and the Focus Motion Knee Brace to capture the data listed in attachment section. The results of this data will be compared to the control group to see if there is or there is not a difference in clinical outcomes with patients receiving Total knee surgery using the MAKO surgical robot versus those who got Total knee surgery without the MAKO robot.

Detailed Description
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Research objectives: The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Mean weekly VAS pain score during the first 4 weeks is the primary end point. Results of this study will be compared to prospective cohort of patients in the IRB study 201805014 from this institution who underwent TKA using non-robotic, manual instruments Primary Hypothesis: Patients receiving robotic TKA will have better early recovery, including lower mean weekly VAS pain score for the first 4 weeks postoperatively and higher functional outcome scores, than the manual TKA historical cohort. Secondary Hypothesis: Patients receiving robotic TKA will have more accurate component position and alignment than the manual TKA historical cohort. Potential Contribution: This study would give us a better understanding of the clinical and radiographic outcomes of patients receiving robotic TKA versus manual TKA. It will identify potential advantages and disadvantages of robotic TKA using the MAKO surgical robot.

Official Title
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Early Outcomes of Total Knee Arthroplasty Using the MAKO Surgical Robot and Triathlon Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Device: Robotic MAKO total knee
* Device: FocusMotion knee brace
* Device: Fitbit tracking device
* Device: FocusMotion app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planning to undergo Unilateral primary total knee arthroplasty 18 and up Willing to sign informed consent Willing to return for all follow-up visits Smartphone or tablet device capable of running the Fitbit andFocusMotion platform Exclusion Criteria: BMI > 45 Inflammatory arthritis Narcotic use greater than 5 days per week Walking aid for musculoskeletal or neurologic issue other than operative joint Bilateral total knee arthroplasty Patient with an active infection or suspected infection in the operative joint The absolute and relative contraindications stated in the FDA cleared labeling for the device

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Group- Robotic TKA Arm<br>Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine | Device: Device: Robotic MAKO total knee<br>* Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine<br>Device: FocusMotion knee brace<br>* Focusmotion knee brace measures range of motion during exercises<br>Device: Fitbit tracking device<br>* Fitbit will measure patients steps, HR, and sleep<br>Device: FocusMotion app<br>* Will survey patients with PROMS<br>|
| Control- manual total Knee arthroplasty<br>Patients who have had a manual total knee arthroplasty | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early recovery | To determine if Robotic-arm assisted TKA (RA-TKA) allows for earlier recovery than manual TKA (MI-TKA). This will be measured by weekly VAS pain score. [Time Frame: 1 day- post op] | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post op EOS measurements for alignment | To determine if Robotic-arm assisted TKA (RA-TKA) allows for more accurate component placement than manual TKA (MI-TKA). units of measurement will be inches. | 1 year |