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Surgeons use navigation tools to measure knee stability during surgery

NCT ID NCT03441165

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study measures how loose the knee is during surgery for ACL reconstruction, ACL revision, or meniscus transplantation. Researchers use a navigation system and a special device to track knee movement in real time. The goal is to gather data that may help improve surgical techniques. The study involves 1,500 participants aged 14 to 65.

What this could mean

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

What this could lead to
If successful, this could help surgeons better understand knee stability during surgery, potentially leading to improved techniques for ACL reconstruction and meniscus transplantation.
What could go wrong
This is an observational study focused on measurement, not a treatment. It may not directly lead to better patient outcomes, and results may not apply to all knee surgeries.

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.

Participants

About 1,500 people

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

Started

Feb 2018

Expected to finish

Jun 2032

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.

Who is studied

The study aims to include all patients who will undergo anterior cruciate ligament reconstruction, anterior cruciate ligament revision or meniscus transplantation. These patients will undergo an intraoperative kinematic evaluation (pre- and post-ligament reconstruction / meniscal transplantation). There is no follow-up because all the data necessary to carry out the study are obtained during the operating session. In particular, the pre- and post-intervention acquired values (intraoperatively) will be compared both by the surgical navigator and by the KiRA system in order to evaluate the effect of surgery on the value of both static and dynamic laxity of the knee joint. Moreover, limited to the data acquired with the KiRA system, a comparison will also be made with the lateral limb.

Ages

14 to 65 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: 1. Patients who have provided written informed written consent 2. Patients aged 14 to 65 3. Patients undergoing reconstructive surgery of the anterior cruciate ligament or revision of anterior cruciate ligament surgery or meniscus transplantation. Patients unable to understand and want patients who have not signed informed consent Exclusion Criteria: 1. Patients unable to understand and to want 2. Patients who have not signed informed consent

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Conditions

The condition(s) this trial relates to.

injury

As listed by the trial registrant

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

Intraoperative musculoskeletal injury

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

  • Stefano Zaffagnini

    RECRUITING

    Bologna, Italia, Italy