NCT05744895

MAKO Total Knee Artroplasty

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 123 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-14
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2023-02-27
• Last updated: 2026-02-17
• Results posted: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study