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Robotic knee surgery put to the test in 252-Patient study

NCT ID NCT04338893

Disease control Sponsor: Zimmer Biomet 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether using a robotic system (ROSA) during knee replacement surgery leads to more accurate implant placement compared to traditional methods. It included 252 adults with knee pain, arthritis, or deformities who were already scheduled for knee replacement. Researchers measured alignment accuracy with CT scans and also tracked surgery time and patient-reported outcomes.

What this could mean

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

Active substance
ROSA Knee System (robotic surgical device) used with Persona, NexGen, or Vanguard total knee implants
What this could lead to
If successful, this could show that robotic-assisted knee replacement leads to more accurate implant placement and better patient outcomes.
What could go wrong
This is a completed post-market study, not a randomized trial, so results may not prove superiority. Robotic surgery may not improve pain or function for 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

252 people

The number who actually took part.

Started

Dec 2020

Finished

Aug 2025

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/Exclusion criteria Inclusion criteria: * Patient is a minimum of 18 years of age * Independent of study participation, patient is a candidate for commercially available Persona, NexGen, or Vanguard knee components implanted in accordance with product labeling * Patient has participated in this study-related Informed Consent Process * Patient is willing and able to provide written Informed Consent by signing and dating the EC approved Informed Consent form * Patient is willing and able to complete scheduled study procedures and follow-up evaluations Exclusion criteria: * Patient is currently participating in any other surgical intervention studies or pain management studies * Patient has underwent contralateral UKA or TKA within the last 18 months * Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum) * Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation) * Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) * Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

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Conditions

The condition(s) this trial relates to.

Genu Valgum osteoarthritis rheumatoid arthritis

As listed by the trial registrant

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

Avascular necrosis of the femoral condyle Chronic osteoarthritis Knee pain Moderate varus, valgus or flexion deformities Rheumatoid arthritis

Contacts and locations

Locations

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Evangelisches Waldkrankenhaus Spandau

    Spandau, Germany

  • Herzogin Elisabeth Hospital

    Braunschweig, Germany

  • Hôpitaux Universitaires de Genève

    Geneva, Switzerland

  • San Giuseppe Hospital

    Arezzo, Italy

  • The Research Fund of Hadassah Medical Organization

    Jerusalem, Israel

More trials for these conditions

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