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Robots take on knee surgery: could precision mean less pain?

NCT ID NCT03519269

Symptom relief Sponsor: Columbia University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study compares robotic-assisted total knee replacement to the standard manual procedure in 86 adults aged 40-85 with severe knee arthritis. Participants will receive the same knee implant, but one group's surgery is guided by a robotic system. Researchers will measure pain, stiffness, physical function, and mobility up to two years after surgery to see if the robotic approach leads to better outcomes.

What this could mean

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

Active substance
Robotic-assisted surgical system (Navio™)
What this could lead to
If successful, robotic-assisted knee replacement could lead to better implant placement, less pain, and faster recovery than conventional surgery.
What could go wrong
This is a small, early-stage study (86 people) comparing two surgical techniques. The robotic system may not improve outcomes significantly, and results may not apply to all patients.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

99 people

The number who actually took part.

Started

Apr 2019

Expected to finish

Dec 2026

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.

Ages

40 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * age between 40 and 85 * body mass index (BMI) less than 40.0 kg/m\^2 * end-stage knee osteoarthritis (Kellgren and Lawrence grade 4) * failure of a minimum 12 weeks of nonoperative management * English fluency Exclusion Criteria: * history of inflammatory arthropathy in the same knee * history of prior open knee surgery in the same knee * history of prior osteotomy or periarticular fracture * deformity \> 15 degrees from a neutral mechanical axis * gross ligamentous incompetence of the medial or lateral collateral ligaments * musculoskeletal involvement beyond unilateral knee osteoarthritis significantly limiting their function * unwillingness or inability to participate in the proposed study protocol and follow-up

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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.

Osteoarthritis, knee

Contacts and locations

Locations

  • Columbia University Medical Center

    New York, New York, 10032, United States

More trials for these conditions

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