Osteoarthritis, KneeNCT05744895
MAKO Total Knee Artroplasty
An observational study of Osteoarthritis, Knee, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Device: Robotic MAKO total knee, FocusMotion knee brace and Fitbit tracking device
- Type of treatment
- Medical device
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We propose to enroll patients that are scheduled for a MAKO Total knee arthroplasty
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
Creve Coeur, Missouri, 63141
About this study
Official title: 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.
Read the 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
- Being tested
- Device: Robotic MAKO total knee, FocusMotion knee brace, Fitbit tracking device, FocusMotion app
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Prospective Group- Robotic TKA Arm | Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine Receives: Device: Device: Robotic MAKO total knee; Device: FocusMotion knee brace; Device: Fitbit tracking device; Device: FocusMotion app | |
| Control- manual total Knee arthroplasty | Patients who have had a manual total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 week
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start14 Sep 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Sponsor
- Investigators
- Charles Hannon, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744895
- Sponsor's protocol ID
- 202106145
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2023
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcomes of Total Knee Arthroplasty Using the MAKO Surgical Robot and Triathlon Knee
- ClinicalTrials.gov ID
- NCT05744895
- Acronym / sponsor ID
- 202106145
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Group- Robotic TKA Arm | – | Device: Device: Robotic MAKO total knee, Device: FocusMotion knee brace, Device: Fitbit tracking device, Device: FocusMotion appProspective TKA patient receiving total knee arthroplasty using the MAKO robotic machine |
| Control- manual total Knee arthroplasty | – | –Patients who have had a manual total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We propose to enroll patients that are scheduled for a MAKO Total knee arthroplasty
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Robotic MAKO total kneeProspective TKA patient receiving total knee arthroplasty using the MAKO robotic machine | Device | Prospective Group- Robotic TKA Arm |
| FocusMotion knee braceFocusmotion knee brace measures range of motion during exercises | Device | Prospective Group- Robotic TKA Arm |
| Fitbit tracking deviceFitbit will measure patients steps, HR, and sleep | Device | Prospective Group- Robotic TKA Arm |
| FocusMotion appWill survey patients with PROMS | Device | Prospective Group- Robotic TKA Arm |
Primary outcome
Early Recovery
Time frame: 1 week
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 secondary outcome
Post op EOS Measurements for Alignment
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Hannon, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Recovery (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.