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Which graft works best for Second-Time ACL surgery?

NCT ID NCT07671235

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Updated 2 times

Summary

This study looks at 150 people needing a second ACL reconstruction after the first graft failed. Researchers will compare outcomes between using a graft from the patient's own body (autograft) versus a donor graft (allograft). The goal is to see which option leads to fewer failures and better knee function over at least two years.

What this could mean

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

Active substance
allograft or autograft (tissue graft used in knee surgery)
What this could lead to
If successful, this study could help surgeons choose the best graft type for revision ACL surgery, potentially reducing re-rupture rates and improving long-term knee health.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all patients, and the follow-up period is limited.

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 150 people

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

Started

Jul 2026

Expected to finish

May 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 among all subjects who underwent revision anterior cruciate ligament reconstruction at the SC Orthopaedic and Trauma Clinic II of the Istituto Ortopedico Rizzoli, with at least 2 years between the surgical procedure and the clinical-radiological reassessment proposed in this study, from 01/01/2016 to 31/12/2024 at the Istituto Ortopedico Rizzoli. Such reassessment is part of routine 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: * Age 18-50 years at the time of surgery * Male and female patients * Patients undergoing revision anterior cruciate ligament (ACL) reconstruction with possible associated procedures, with at least 2 years of follow-up * Written informed consent to participate in the study Exclusion criteria: * Patients lost to follow-up * Refusal to provide informed consent * Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery * Severe obesity (BMI \> 35) * Lower limb conditions preventing full weight-bearing standing during evaluation * Active infection, hematologic disease, or rheumatologic disease at the time of assessment

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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-injury Graft failure

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 Rizzoli Orthopedic Institute

    RECRUITING

    Bologna, Bologna, 40136, Italy

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