NCT05744895

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
8 months until next milestone

Results Posted

Study results publicly available

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

February 1, 2023

Results QC Date

December 16, 2025

Last Update Submit

February 12, 2026

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Post op EOS Measurements for Alignment

    1 year

Study Arms (2)

Prospective Group- Robotic TKA Arm

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

Device: Device: Robotic MAKO total kneeDevice: FocusMotion knee braceDevice: Fitbit tracking deviceDevice: FocusMotion app

Control- manual total Knee arthroplasty

Patients who have had a manual total knee arthroplasty

Interventions

FocusMotion knee braceDEVICE

Focusmotion knee brace measures range of motion during exercises

Prospective Group- Robotic TKA Arm
Fitbit tracking deviceDEVICE

Fitbit will measure patients steps, HR, and sleep

Prospective Group- Robotic TKA Arm
FocusMotion appDEVICE

Will survey patients with PROMS

Prospective Group- Robotic TKA Arm
Device: Robotic MAKO total kneeDEVICE

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

Prospective Group- Robotic TKA Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Planning to undergo Unilateral primary total knee arthroplasty
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

Creve Coeur, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Venessa Riegler
Organization
Washington University
rieglerv@wustl.edu
314-362-1721

Study Officials

  • Charles Hannon, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 27, 2023

Study Start

September 14, 2021

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 17, 2026

Results First Posted

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)