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Knee surgery for Over-50s: does a specialized ACL technique match younger Patients' results?

NCT ID NCT07041242

Disease control Sponsor: Stefano Zaffagnini Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This study compares outcomes of a specific ACL reconstruction technique, called over-the-top with lateral extra-articular tenodesis (LET), in patients over 50 years old versus those under 30. The technique uses the patient's own hamstring tendons and adds an extra procedure to stabilize the knee. Researchers will track complications and knee function using validated scores to see if older patients benefit as much as younger ones.

What this could mean

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

Active substance
ACL reconstruction using the single-bundle over-the-top technique with hamstring tendons, combined with lateral extra-articular tenodesis (LET)
What this could lead to
If successful, this could show that older adults can safely undergo ACL reconstruction with the over-the-top plus LET technique, potentially reducing reinjury risk and improving knee stability in this age group.
What could go wrong
This is an observational comparison, not a randomized trial, so results may be influenced by patient differences. The study is also retrospective, and outcomes depend on patient-reported measures, which may not capture all complications.

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 164 people

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

Started

Jul 2025

Expected to finish

Jun 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 will be recruited from both male and female subjects over 50 years of age at the time of surgery (study group), and adult patients, also both male and female, aged between 18 and 30 years at the time of surgery (control group), who underwent surgical treatment at the II Clinic of the Rizzoli Orthopaedic Institute by means of single-bundle "over-the-top" anterior cruciate ligament reconstruction using the gracilis and semitendinosus tendons, combined with lateral extra-articular tenodesis. Only patients at least 2 years post-surgery will be enrolled. Patients will be recruited evenly and progressively to ensure proper matching of the two groups with respect to patient characteristics. For each patient over 50 included in the study, a patient under 30 with similar characteristics (total follow-up duration, sex, concomitant meniscal injuries at the time of surgery) will be included to guarantee a balanced comparison between the two patient cohorts.

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: * Patients operated on between 2007 and 2023 who were over 50 years old at the time of surgery (study group) and patients under 30 years old at the time of surgery (control group). * Patients who underwent ACL reconstruction using the gracilis and semitendinosus tendons with the over-the-top + LET technique. * Patients of both male and female sex. * Patients who have provided consent to participate in the study. Exclusion Criteria: * Previous surgery on the same limb (meniscectomy, prior ACL reconstruction, surgically treated fractures, osteotomies, meniscal transplants). * Concomitant surgery on the same limb (osteotomies, meniscal transplants). * Surgical technique different from the over-the-top with LET using autologous gracilis and semitendinosus tendons. * Other concomitant ligament injuries requiring surgical treatment. * Patients younger than 18 years at the time of surgery (minors) or patients aged between 30 and 50 years at the time of surgery. * Patients who have not provided informed consent. * Patients with a follow-up period shorter than 2 years.

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Conditions

The condition(s) this trial relates to.

lupus erythematosus tumidus

As listed by the trial registrant

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

ACL Hamstring muscles LET

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, Bologna, 40136, Italy

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