MAKO Total Knee Artroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Device: Robotic MAKO total knee; Device: FocusMotion knee brace; Device: Fitbit tracking device; Device: FocusMotion app

Detailed Description

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 (Actual): 123

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We propose to enroll patients that are scheduled for a MAKO Total knee arthroplasty

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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. VAS scale 0-10 (0= no pain, 10=extreme pain)	1 week

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Stryker Nordic
• Investigators: Principal Investigator: Charles Hannon, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 202106145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No