RECRUITING

The Pediatric ALL Evaluation and Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Pediatric ALL Evaluation and Trial: A Randomized, Controlled Trial

Quick Facts

Study Start:2021-04-28
Study Completion:2028-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04825587

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 and under
  2. * Surgery within 6 months of injury
  3. * Undergoing primary ACL reconstruction without previous injury or surgery
  4. * Quadriceps tendon autograft ACL reconstruction
  5. * Closing or closed physes
  1. * Over 18 years old
  2. * Previous ipsilateral knee injury or surgery
  3. * Neuromuscular or developmental disorders affecting knee anatomy, cognition, or neuromuscular control
  4. * Other concomitant ligament reconstruction aside from the ALL (i.e., MCL, PCL, PLC)
  5. * Revision ACL reconstruction
  6. * ACL reconstruction with graft other than quadriceps tendon
  7. * IT band (modified MacIntosh) ACL reconstruction
  8. * A cartilage lesion requiring anything more than debridement
  9. * Open physes requiring both femoral and tibial physeal-sparing technique

Contacts and Locations

Study Contact

Amanda Kass
CONTACT
312-227-1267
akass@luriechildrens.org
Neeraj Patel, MD
CONTACT
312-227-6190
neepatel@luriechildrens.org

Principal Investigator

Neeraj Patel, MD
PRINCIPAL_INVESTIGATOR
Lurie Children's Hospital

Study Locations (Sites)

Lurie Children's Hospital
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

  • Neeraj Patel, MD, PRINCIPAL_INVESTIGATOR, Lurie Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-28
Study Completion Date2028-04-01

Study Record Updates

Study Start Date2021-04-28
Study Completion Date2028-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • ACL Injury
  • ACL Tear