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Knee surgery study: does an extra stabilization step help ACL patients?

NCT ID NCT07049484

Knowledge-focused Sponsor: Stefano Zaffagnini 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at people having ACL knee surgery with an extra procedure called LET, which aims to improve knee stability. Researchers will measure how stable the knee is during early recovery using special devices. The goal is to help doctors and physical therapists create better rehab plans for patients returning to sports.

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 51 people

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

Started

Mar 2026

Expected to finish

Jun 2029

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 will be recruited from those surgically treated at the Second Clinic of the Rizzoli Orthopaedic Institute, undergoing anterior cruciate ligament reconstruction using the "over-the-top" single-bundle technique with gracilis and semitendinosus tendons, combined with lateral extra-articular tenodesis (LET). Only patients with at least 6 months of follow-up after the surgery date will be enrolled. Subsequently, patients will be re-evaluated during a 12-month follow-up visit, as per standard clinical practice for this procedure.

Ages

18 to 50 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: * Patients undergoing isolated ACL reconstruction using gracilis and semitendinosus tendons with the over-the-top technique and LET. * Both male and female patients. * Patients who have given consent to participate in the study. * Age between 18 and 50 years at the time of surgery. Exclusion Criteria: * Previous surgery on the same limb (meniscectomy, prior ACL reconstruction, displaced fractures). * Surgical technique different from Over-the-Top with LET using autologous gracilis and semitendinosus tendons. * Other concomitant ligament injuries requiring surgical treatment. * Patients undergoing additional procedures at the same time as ACL reconstruction and LET (e.g., concomitant osteotomy, meniscus transplant, cartilage procedure…). * Patients who did not provide informed consent.

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries

As listed by the trial registrant

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

Acl injuries Acl reconstruction Tenodesis

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

  • IRCCS Istituto Ortopedico Rizzoli

    RECRUITING

    Bologna, 40136, Italy

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