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Could an extra stitch save Kids' ACL repairs? new trial aims to find out

NCT ID NCT04825587

Disease control Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether repairing an additional knee ligament (the ALL) at the same time as standard ACL surgery can lower the chance of the ACL graft failing in children. About 240 kids aged 18 and under who need ACL surgery will be randomly assigned to get either the standard surgery alone or the standard surgery plus the extra ligament repair. The goal is to see if the combined approach leads to fewer re-tears and better long-term knee function.

What this could mean

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

Active substance
surgical procedure (concomitant ACL and ALL reconstruction)
What this could lead to
If successful, this could lead to a standard surgical approach that lowers the risk of ACL graft failure in children, improving long-term knee stability.
What could go wrong
This is a relatively early-stage trial with 240 participants, so results may not apply to all children. Adding ALL reconstruction could increase surgical complications without clear benefit.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

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

Started

Apr 2021

Expected to finish

Apr 2030

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.

Ages

Up to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 and under * Surgery within 6 months of injury * Undergoing primary ACL reconstruction without previous injury or surgery * Quadriceps tendon autograft ACL reconstruction * Closing or closed physes Exclusion Criteria: * Over 18 years old * Previous ipsilateral knee injury or surgery * Neuromuscular or developmental disorders affecting knee anatomy, cognition, or neuromuscular control * Other concomitant ligament reconstruction aside from the ALL (i.e., MCL, PCL, PLC) * Revision ACL reconstruction * ACL reconstruction with graft other than quadriceps tendon * IT band (modified MacIntosh) ACL reconstruction * A cartilage lesion requiring anything more than debridement * Open physes requiring both femoral and tibial physeal-sparing technique

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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 tear Acl-injury

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

  • Lurie Children's Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

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