N/A
N=237
MAKO Total Knee Artroplasty
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT05744895 ↗Enrolled (actual)
237
Serious AEs
0.5%
Results posted
Feb 2026
Primary outcome: Primary: Early Recovery — 3.6; 4.2 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Device: Robotic MAKO total knee (Device); FocusMotion knee brace (Device); Fitbit tracking device (Device); FocusMotion app (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early Recovery |
3.6; 4.2 | — |
| SECONDARY Post op EOS Measurements for Alignment |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05744895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.