Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

Study Overview
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Brief Summary
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To determine if robotically-assisted UKA results in more consistent and improved component positioning and better patient reported outcome scores compared to manual TKA and MAKO TKA.

Detailed Description
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The purpose of this study is to determine the early clinical and radiographic outcomes of robotically-assisted medial unicompartmental knee arthroplasty (mUKA) with the MAKO surgical robot using the Restoris MCK Partial Implant System. The primary end point will be the mean weekly VAS pain score during the first four weeks postoperatively. The results of this study may be compared to those of previously studied cohorts of patients from this institution who underwent manual total knee arthroplasty (TKA) with the Triathlon Knee System as well as robotically-assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon Knee System

Official Title
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Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: focus motion knee brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. Unilateral primary medial unicompartmental knee arthroplasty B. Age 18 years of age or older C. Willing to sign informed consent D. Willing to return for all follow-up visits E. Smartphone or tablet device capable of running the FocusMotion platform Exclusion Criteria: A. BMI > 40 B. Personal history of DVT or PE C. Inflammatory arthritis D. Peripheral vascular disease E. Opioid use greater than 5 days per week F. Nonsteroidal anti-inflammatory allergy G. Walking aid for musculoskeletal or neurologic issue other than operative joint H. Bilateral medial unicompartmental knee arthroplasty I. Patient with an active infection or suspected infection in the operative joint J. 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

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UKA MAKO<br>Prospective group- Patient Reported Outcomes (PROs) will be assessed using the FocusMotion app survey | Device: focus motion knee brace<br>* knee brace that captures knee motion<br>|
| TKA MAKO<br>Control group-Already collected data on patient reported out comes using the FocusMotion app survey | Device: focus motion knee brace<br>* knee brace that captures knee motion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported Questionnaires for weekly VAS pain scores up weekly | Patients will assess their weekly pain scores by filling out patient reported outcomes. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient will track their Opioid Consumption use by filling out a chart weekly | Patients will report their weekly use by Opioid Consumption filling out a patient diary. | 3 months |