CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 123 enrolled
Drug / intervention
Device: Robotic MAKO total knee +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05744895
NCT05744895N/ACompleted

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

Washington University School of Medicine·observational·Posted Feb 27, 2023·Updated Feb 17, 2026

In Brief

An observational study evaluating Device: Robotic MAKO total knee, FocusMotion knee brace, and 2 other interventions for Osteoarthritis, Knee. Completed, enrolled 123 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsStryker Nordic

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 27, 2023
Enrollment StartSep 14, 2021
Primary CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 3.3 years ago

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