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New italian knee questionnaire aims to improve ACL recovery tracking

NCT ID NCT07386405

Knowledge-focused Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to translate and validate the KOOS-ACL questionnaire for Italian-speaking patients who have had anterior cruciate ligament (ACL) reconstruction. Researchers will enroll 120 native Italian speakers aged 18 or older to test the accuracy and cultural relevance of the Italian version. The goal is to provide a reliable tool for assessing knee injury and recovery in this population.

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 will provide a reliable Italian version of the KOOS-ACL questionnaire, helping doctors better assess knee recovery after ACL surgery in Italian patients.
What could go wrong
This is a validation study, not a treatment trial. It focuses on measuring outcomes, not improving them, so it won't directly change patient health.

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 120 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jul 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.

Who is studied

Patients with a diagnosis of anterior cruciate ligament injury, undergoing or being considered for ACL reconstruction surgery.

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: * Patient age 18 years or older * Patients who are native Italian speakers * Patients undergoing anterior cruciate ligament reconstruction of the knee * Patients who have understood and signed the informed consent to participate in the study. * Patients who are able to understand the study conditions and participate for the entire duration Exclusion Criteria: * Patients unable to understand the text in Italian * Patients undergoing knee replacement surgery, corrective osteotomies, or osteosynthesis of knee fractures. * Patients who are drug addicts, alcoholics, suffer from psychiatric disorders, or have any clinical conditions that could compromise the success of the questionnaire. * Patients with orthopedic conditions of other origins

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries posterior leukoencephalopathy syndrome

As listed by the trial registrant

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

Acl-injury PROMS Scale reliability validity Validation and cultural adaptation of A scale

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Istituto Clinico San Siro

    Milan, Italy

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