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Robot-Assisted knee surgery shows promise in alignment study

NCT ID NCT04786119

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a robotic system called CORI that helps surgeons plan and perform knee replacement surgery. The goal was to see if the robot helps place the new knee joint more accurately. 126 adults who needed a partial or total knee replacement took part. The results showed that the robot helped achieve good leg alignment in most 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

126 people

The number who actually took part.

Started

Feb 2021

Finished

Sep 2024

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: * The subject's treating clinician has decided that REAL INTELLIGENCE™ CORI™ and a compatible Smith+Nephew Knee Implant System is the best treatment for the subject's unicondylar knee arthroplasty (UKA) or total knee arthroplasty (TKA) and the subject has agreed to the treatment. * Subject requires a cemented UKA or TKA as a primary indication that meets either criterion A or B. * A. Subject requires a cemented UKA as a primary indication due to any of the following conditions: 1. Non-inflammatory degenerative joint disease, including osteoarthritis 2. Avascular necrosis 3. Requires correction of functional deformity 4. Requires treatment of fractures that were unmanageable using other techniques * B. Subject requires a cemented TKA as a primary indication due to any of the following condition: 1. Degenerative joint disease, including osteoarthritis 2. Rheumatoid arthritis 3. Avascular necrosis 4. Requires correction of functional deformity 5. Requires treatment of fractures that were unmanageable using other techniques * Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery) * 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. * Subject plans to be available through one (1) year postoperative follow-up. * Routine radiographic assessment is possible. * Subject able to follow instructions and deemed capable of completing all study questionnaires. Exclusion Criteria: * Subject receives a CORI Robotics UKA or TKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard UKA or TKA (e.g. stems, augments, or custom made devices). * Subject has been diagnosed with post-traumatic arthritis * Subject receives bilateral UKA or TKA * Subject does not understand the language used in the Informed Consent Form. * Subject does not meet the indication or is contraindicated for UKA or TKA according to specific Smith+Nephew knee system's Instructions For Use (IFU). * Subject has active infection or sepsis (treated or untreated). * Subject is morbidly obese with a body mass index (BMI) greater than 40. * Subject is pregnant or breast feeding at the time of surgery. * 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. * Subject has a condition(s) that may interfere with the TKA or UKA 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). * 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, mental retardation, drug or alcohol abuse. * Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint. * Subject is a prisoner or meets the definition of a Vulnerable Subject per ISO 14155 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.

Contacts and locations

Locations

  • Duke Health

    Morrisville, North Carolina, 27560, United States

  • Lokmanya Hospital

    Pune, Maharashtra, 411044, India

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • OrthoNeuro

    New Albany, Ohio, 43054, United States

  • Orthopaedic clinic of the Medical School Hannover

    Hanover, 30625, Germany

  • Orthopedic Institute of the West

    Phoenix, Arizona, 85054, United States

  • Pius-Hospital Oldenburg

    Oldenburg, 26121, Germany

  • The Royal Orthopaedic Hospital NHS Foundation Trust

    Birmingham, West Midlands, B31 2AP, United Kingdom

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