Recruiting

ACL & ALL

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Code:

NCT04825587

Conditions

ACL Injury

ACL Tear

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Interventions

Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.

Study Details

Brief summary:

The overall aim of this multicenter RCT is to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure than ACL reconstruction alone.

Conditions

ACL Injury

ACL Tear

Study ID

NCT04825587

Start date

Apr 28, 2021

Status verified date

Mar, 2026

Completion date

Apr 1, 2030

Anticipated

Primary completion date

Apr 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Concomitant ACL and ALL reconstruction

The participant will undergo both the ACL and ALL reconstruction surgery.

experimental: ACL reconstruction alone

The participant will undergo only ACL reconstruction surgery.

Interventions

Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.

By randomizing patients into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone, following statistical analysis, we hope to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure than ACL reconstruction alone.

Primary outcome measure

  • Graft failure [ Time Frame: Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years. ]

Central Contacts and Locations

Central contacts

Amanda Kass

312-227-1267akass@luriechildrens.org

Neeraj Patel, MD

312-227-6190neepatel@luriechildrens.org

Locations

Lurie Children's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Amanda Kass

(312) 227-1267akass@luriechildrens.org

Principal Investigator:

Neeraj Patel, MD

More Information

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Last update posted

May 29, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago on 2026-05-29.