MAKO Total Knee Artroplasty

Washington University School of Medicine123 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

123

Conditions

Osteoarthritis, Knee

Interventions

Device: Robotic MAKO total kneeDEVICE

Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine

FocusMotion knee braceDEVICE

Focusmotion knee brace measures range of motion during exercises

Fitbit tracking deviceDEVICE

Fitbit will measure patients steps, HR, and sleep

FocusMotion appDEVICE

Will survey patients with PROMS

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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. VAS scale 0-10 (0= no pain, 10=extreme pain)

Time frame: 1 week

Secondary Outcomes

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.

Time frame: 1 year