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Second-Time ACL repair: new technique shows promise for knee stability

NCT ID NCT06868147

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study looks at how well a particular revision ACL surgery works over the long term. The technique uses a donor Achilles tendon and an extra stitch on the outside of the knee. Researchers will check knee function, stability, and arthritis development in 59 people who had this surgery at least two years ago.

What this could mean

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

Active substance
Achilles tendon allograft
What this could lead to
If successful, this technique could offer a reliable option for people needing a second ACL repair, potentially reducing knee instability and delaying arthritis.
What could go wrong
This is a small, single-center study with no control group, so results may not apply to everyone. The surgery is complex and carries standard risks like infection or graft failure.

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 59 people

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

Started

Mar 2025

Expected to finish

Jan 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 all subjects who underwent revision of anterior cruciate ligament reconstruction with the single-bundle "Over-The-Top" technique and external tenodesis using Achilles tendon allograft at the SC Orthopedic and Traumatology Clinic II of the Rizzoli Orthopedic Institute, at least 2 years after the surgical procedure and the clinical-radiological reassessment proposed in this study, between 1/1/2000 and 31/12/2022 at the Rizzoli Orthopedic Institute. This reassessment is part of standard clinical practice.

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: 1. Age between 18 and 50 years at the time of surgery; 2. Male and female gender; 3. Patients who have undergone revision of anterior cruciate ligament reconstruction with a single-bundle "Over-The-Top" technique and external tenodesis using Achilles tendon allograft, with or without associated procedures, at least 2 years post-surgery; 4. A radiograph taken immediately before or after the surgery of the affected knee; 5. Patients who have provided consent to participate in the study. Exclusion Criteria: 1. Patients no longer accessible; 2. Patients who deny consent to participate in the study; 3. Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery; 4. Severe obesity (BMI \> 35); 5. Lower limb conditions that prevent the patient from maintaining an upright position with full weight-bearing during the assessment; 6. Infection or hematological or rheumatic conditions at the time of the assessment.

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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 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, 40136, Italy

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