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Robot arm takes on knee surgery: will it keep implants tight?

NCT ID NCT05204797

Knowledge-focused Sponsor: Istituto Ortopedico Rizzoli 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 robot-assisted knee replacement to the standard manual technique in 50 patients with partial knee arthritis. The goal is to see which method better prevents early implant loosening, measured with special X-rays. Participants will be followed for two years 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
Robot-assisted surgical procedure (CORI Surgical System)
What this could lead to
If robot-assisted surgery reduces early implant loosening, it could improve long-term success of partial knee replacements.
What could go wrong
This is a small, early-stage study with only 50 participants, so results may not apply widely. The robot may not offer a clear advantage over standard techniques.

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 50 people

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

Started

Oct 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

50 to 80 years

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: * Unicompartmental Knee Arthrosis * Femoral condyles or medial tibial plate osteonecrosis * Healthy anterior cruciate ligament, posterior cruciate ligament and collateral ligaments of the affected knee * Post traumatic loss of joint configuration * Moderate varism deformity * Patients between 50 and 80 years old * Patients able to undergo a 2-year follow up after surgery Exclusion Criteria: * Bi or Tricompartmental arthrosis * Unhealty anterior or posterior cruciate ligaments or collateral ligaments * Patients with neuromuscolar, degenerative and joint-related conditions * Patients younger than 50 * Patients older than 80 * Patients unable to undergo a 2-year follow up after surgery

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee Prosthesis Failure

As listed by the trial registrant

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

Loosening, prosthesis

Contacts and locations

Locations

  • IRCCS Istituto Ortopedico Rizzoli

    Bologna, Emilia-Romagna, 40136, Italy

More trials for these conditions

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