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New ACL surgery combo aims to cut Re-Tear rate in young athletes

NCT ID NCT03935750

Disease control Sponsor: University of Pittsburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two different tendon grafts (kneecap tendon vs. quadriceps tendon) for ACL reconstruction, with or without an extra stabilizing procedure called lateral extra-articular tenodesis (LET). The goal is to see which approach best prevents graft failure in 1,272 young, active people aged 14-25 who are at high risk of re-injury. Participants are randomly assigned to one of four surgery combinations and followed for 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
Anterior cruciate ligament reconstruction (ACLR) with bone-patellar-tendon-bone or quadriceps tendon autograft, with or without lateral extra-articular tenodesis (LET)
What this could lead to
If successful, this could establish a standard surgical approach that lowers the chance of ACL graft failure and re-injury in young, active people.
What could go wrong
This is a surgical technique study, not a drug trial. Results may not apply to all patients, and adding LET could increase the risk of arthritis in the outer knee.

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

1,272 people

The number who actually took part.

Started

Jul 2020

Expected to finish

May 2028

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

14 to 25 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 14-25, * An ACL-deficient knee, * Skeletal maturity (i.e. closed epiphyseal growth plates on standard knee radiographs), * At least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity (Beighton score of ≥4) and/or genu recurvatum \>10 degrees. Exclusion Criteria: * Previous ACLR on either knee, * Partial ACL injury (defined as one bundle ACL tear requiring reconstruction/augmentation of the torn bundle with no surgery required for the intact bundle), * Multiple ligament injury (two or more ligaments requiring surgery), * Symptomatic articular cartilage defect requiring treatment other than debridement, * \>3 degrees of asymmetric varus, * Inflammatory arthropathy, * Inability to provide consent, * Pregnancy at baseline.

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries Joint Instability joint laxity, familial

As listed by the trial registrant

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

Anterior cruciate ligament injury Anterior cruciate ligament reconstruction Joint instability

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Banff Sport Medicine Clinic

    Banff, Alberta, T1L 1B3, Canada

  • Cologne-Merheim Medical Center, Klinik für Orthopädie, Unfallchirurgie und Sporttraumatologie

    Cologne, 51109, Germany

  • Dublin City University / UPMC Sports Surgery Clinic

    Dublin, Dublin 9, D09 C523, Ireland

  • Fowler Kennedy Sport Medicine Clinic

    London, Ontario, N6A 3K7, Canada

  • Fraser Health Authority

    New Westminster, British Columbia, V3L 5P5, Canada

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • McMaster University

    Hamilton, Ontario, L8N 3Z5, Canada

  • Med Center Health

    Bowling Green, Kentucky, 42101, United States

  • North Bristol Trust

    Bristol, BS10 5NB, United Kingdom

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 3A6, Canada

  • Ochsner Clinic Foundation

    Baton Rouge, Louisiana, 70836, United States

  • Orlando Health Jewett Orthopedic Institute

    Orlando, Florida, 32806, United States

  • Oslo University Hospital

    Oslo, 0372, Norway

  • Pan Am Clinic

    Winnipeg, Manitoba, R3M 3E4, Canada

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • Stanford University

    Redwood City, California, 94063, United States

  • Stockholm South Hospital, Karolinska Institutet

    Stockholm, 922M+CC, Sweden

  • The Rector and Visitors of the University of Virginia

    Charlottesville, Virginia, 22903, United States

  • University Hospitals Coventry and Warwickshire NHS Trust

    Coventry, CV2 2DX, United Kingdom

  • University Klinik Münster

    Münster, 48149, Germany

  • University of Calgary Sport Medicine Centre

    Calgary, Alberta, T2N 1N4, Canada

  • University of California, San Francisco

    San Francisco, California, 94158, United States

  • University of Kentucky

    Lexington, Kentucky, 40504, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • University of Ottawa

    Ottawa, Ontario, K1N 6N5, Canada

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260, United States

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27101, United States

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