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Robot vs surgeon: which knee replacement works better?

NCT ID NCT07551856

Symptom relief Sponsor: Golden Jubilee National Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 1 time

Summary

This study compares two types of total knee replacement surgery for people with knee osteoarthritis: one done manually and one assisted by a robotic device (VELYS). About 346 participants will be randomly assigned to one of the two surgeries and followed for a year to see which leads to better pain relief, function, and satisfaction. The goal is to find out if robotic assistance improves outcomes and reduces complications.

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 346 people

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

Started

Jul 2026

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Aged \>18 years * Primary knee OA * Requiring TKA * Suitable for either raTKA or mTKA * Capable to provide written informed consent * Capable and willing to complete outcome measures throughout study period Exclusion Criteria: * Inflammatory arthritis * Significant symptomatic hip, ankle, or contralateral knee OA * Prior TKA or major injury or major surgery on the index knee * Neuromuscular gait disorders * BMI \>45 kg/m2 * Coronal plane deformity \>15° varus/valgus on pre-op HKA radiograph * Fixed flexion deformity greater than 15° * Bone loss likely to require non-standard implants (e.g. stems, augments) * Severe deformity or ligament insufficiency likely to require constraint * Inability to comply with the required follow-up assessments or complete PROMs * Contraindications to any aspect of the surgical technique

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

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

Knee osteoarthritis Osteo arthritis Osteo arthritis of the knee Osteoarthritis Osteoarthritis (OA) Osteoarthritis in the knee Osteoarthritis, knee

How to take part

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

  1. The places running it

    1 site. 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

  • Golden Jubilee University National Hospital

    RECRUITING

    Glasgow, Scotland, G81 4HX, United Kingdom

More trials for these conditions

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