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Robot surgeon takes on knee replacements – will it beat the human hand?

NCT ID NCT04848896

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a robot-assisted system (CORI) to conventional manual instruments for total knee replacement. About 140 participants will be randomly assigned to one of the two methods. The main goal is to see if the robot helps achieve more precise leg alignment after surgery.

What this could mean

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

Active substance
CORI Robotics surgical navigation and burring system
What this could lead to
If successful, this could show that robot-assisted knee surgery leads to more accurate leg alignment than traditional methods.
What could go wrong
This is a relatively small, early-stage study focused on alignment, not long-term outcomes. The robot may not improve pain or function, and device-related risks include infection or nerve damage.

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

About 140 people

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

Started

Feb 2022

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System. 2. Subject requires a cemented TKA as a primary indication that meets any of the following condition: * Non-inflammatory degenerative joint disease, including osteoarthritis * Rheumatoid arthritis * Avascular necrosis * Requires correction of functional deformity * Requires treatment of fractures that were unmanageable using other techniques 3. Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery) 4. Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form. 5. Subject plans to be available through two (2) year postoperative follow-up. 6. Applicable routine radiographic assessment is possible. Exclusion Criteria: 1. Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (e.g. stems, augments, or custom-made devices). 2. Subject has been diagnosed with post-traumatic arthritis. 3. Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA. 4. Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or UKA, however, the subject can only have one knee enrolled in this study. 5. Subject does not understand the language used in the Informed Consent Form. 6. Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU). 7. Subject has active infection or sepsis (treated or untreated). 8. Subject is morbidly obese with a body mass index (BMI) greater than 40. 9. Subject is pregnant or breast feeding at the time of surgery. 10. Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure. 11. Subject currently enrolled in another orthopedic clinical trial study. 12. Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection). 13. Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse. 14. Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint. 15. Subject is a prisoner or meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2020 Section 3.55.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jishuitan Hospital, Beijing

    RECRUITING

    Beijing, 100035, China

  • North Shore Hospital

    RECRUITING

    Auckland, 0620, New Zealand

  • Northern Hospital

    RECRUITING

    Epping, 3076, Australia

  • The Prince of Wales Hospital

    RECRUITING

    Shatin, Hong Kong

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