The Pediatric ALL Evaluation and Trial

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study ID
NCT04825587
Status
Recruiting
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Conditions

  • ACL Injury
  • ACL Tear

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
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. — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Apr 28, 2021
Status verified
Mar 2026
Primary completion
Apr 1, 2030
Completion
Apr 1, 2030

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Lurie Children's HospitalChicagoIllinois60611
Amanda Kass
[email protected]
(312) 227-1267
Neeraj Patel, MD (PRINCIPAL_INVESTIGATOR)

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Lurie Children's Hospital· Chicago, IL

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