Robot surgeon takes on knee replacements – will it beat the human hand?
NCT ID NCT04848896
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
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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
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
4 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Jishuitan Hospital, Beijing
RECRUITINGBeijing, 100035, China
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North Shore Hospital
RECRUITINGAuckland, 0620, New Zealand
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Northern Hospital
RECRUITINGEpping, 3076, Australia
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The Prince of Wales Hospital
RECRUITINGShatin, Hong Kong
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