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OpenTrials
Completed

NCT Number: NCT05744895

MAKO Total Knee Artroplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

Creve Coeur, Missouri, 63141, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device: Robotic MAKO total knee

Device

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

FocusMotion knee brace

Device

Focusmotion knee brace measures range of motion during exercises

Fitbit tracking device

Device

Fitbit will measure patients steps, HR, and sleep

FocusMotion app

Device

Will survey patients with PROMS

Primary outcomes

  1. Early Recovery

    Time frame: 1 week

    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)

Secondary outcomes

  1. Post op EOS Measurements for Alignment

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Stryker Nordic

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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