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Robots vs. surgeons: can a machine improve knee replacement outcomes?

NCT ID NCT05736601

Disease control Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether robot-assisted knee replacement surgery leads to better results than traditional manual surgery for people with knee osteoarthritis. About 95 participants will receive the robot-assisted procedure and use a special knee brace to track motion. Researchers will measure pain, opioid use, and recovery over time to see if the robotic approach improves outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
robot-assisted knee replacement surgery and a motion-tracking knee brace
What this could lead to
If successful, this could show that robot-assisted surgery leads to better knee placement and less pain after knee replacement.
What could go wrong
This is a small, early-stage study with only 95 people, so results may not apply to everyone. The robot-assisted method may not prove better than standard surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 95 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants 18 years and older who have chosen to partial knee surgery using the mako robotic system.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: A. Unilateral primary medial unicompartmental knee arthroplasty B. Age 18 years of age or older C. Willing to sign informed consent D. Willing to return for all follow-up visits E. Smartphone or tablet device capable of running the FocusMotion platform Exclusion Criteria: A. BMI \> 40 B. Personal history of DVT or PE C. Inflammatory arthritis D. Peripheral vascular disease E. Opioid use greater than 5 days per week F. Nonsteroidal anti-inflammatory allergy G. Walking aid for musculoskeletal or neurologic issue other than operative joint H. Bilateral medial unicompartmental knee arthroplasty I. Patient with an active infection or suspected infection in the operative joint J. The absolute and relative contraindications stated in the FDA cleared labeling for the device

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Knee osteoarthritis

Contacts and locations

Locations

  • Washington University Medical School

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.