The Pediatric ALL Evaluation and Trial
PALLET
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedStudy Start
First participant enrolled
April 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
November 15, 2024
November 1, 2024
6.9 years
March 29, 2021
November 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Graft failure
To determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure (confirmed graft re-tear or asymmetric, increased pivot shift) than ACL reconstruction alone.
Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
Secondary Outcomes (2)
Complications of ALL reconstruction
Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
Patient reported outcome measures
Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
Study Arms (2)
Concomitant ACL and ALL reconstruction
EXPERIMENTALThe participant will undergo both the ACL and ALL reconstruction surgery.
ACL reconstruction alone
EXPERIMENTALThe participant will undergo only ACL reconstruction surgery.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicagolead
- Children's Hospital of Philadelphiacollaborator
- Texas Children'scollaborator
- UCSF Benioff Children's Hospital - San Franciscocollaborator
Study Sites (1)
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neeraj Patel, MD
Lurie Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Orthopedic Surgery & Sports Medicine, Surgery
Study Record Dates
First Submitted
March 29, 2021
First Posted
April 1, 2021
Study Start
April 28, 2021
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
November 15, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- from the study start up/participant recruitment (beginning April 2021) until 1/1/2030
- Access Criteria
- Study personnel only
Collected Participant info that may be collected and shared :Personal and health information, Past/present medical records, Records from study visits/phone calls. Behavioral or mental health info about the participants will be collected and may be shared.The study staff, employees, and Medical Staff of Lurie Children's may use participant's info for this study and share it with study sponsor, POSNA and those working with the sponsor, IRB, Participant's other providers and their staff directly involved in their care, if their provider is a part of the Lurie Children's electronic health information exchange: The Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), or other government offices. We cannot guarantee that those listed above will not share it with others without participant's permission. Participant's names will not be included in any written or verbal reports of study results.