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Procedure

ACL and ALL Reconstruction vs ACL Alone for Anterior Cruciate Ligament Injury (PALLET Trial)

N/A
Recruiting
Led By Neeraj Patel, MD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 and under
Autograft ACL reconstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
Awards & highlights

PALLET Trial Summary

This trial will test whether repairing both the ACL and ALL in children will lower the rate of graft failure compared to repairing the ACL alone.

Who is the study for?
This trial is for children under 18 who need their first ACL (knee ligament) reconstruction surgery within 6 months of injury, using their own tissue. It's not for those with previous knee injuries/surgeries, neuromuscular disorders affecting the knee, or anyone needing more complex knee procedures.Check my eligibility
What is being tested?
The study compares two surgical methods in kids: one adds an extra ligament reconstruction called ALL to the usual ACL repair, and the other does just the ACL repair. The goal is to see if adding ALL lowers the chance of future graft failures.See study design
What are the potential side effects?
Possible side effects include pain at the surgery site, swelling, infection risk increase after surgery, and potential issues with knee movement or stability depending on how well each procedure works.

PALLET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or younger.
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I had ACL reconstruction using my own tissue.
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My growth plates have stopped growing.
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I am having my first ACL surgery without prior injuries or surgeries.

PALLET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Graft failure
Secondary outcome measures
Complications of ALL reconstruction
Patient reported outcome measures

PALLET Trial Design

2Treatment groups
Experimental Treatment
Group I: Concomitant ACL and ALL reconstructionExperimental Treatment1 Intervention
The participant will undergo both the ACL and ALL reconstruction surgery.
Group II: ACL reconstruction aloneExperimental Treatment1 Intervention
The participant will undergo only ACL reconstruction surgery.

Find a Location

Who is running the clinical trial?

UCSF Benioff Children's Hospital - San FranciscoUNKNOWN
Texas Children'sUNKNOWN
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
253 Previous Clinical Trials
5,187,008 Total Patients Enrolled

Media Library

ACL Reconstruction (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04825587 — N/A
Anterior Cruciate Ligament Tear Research Study Groups: ACL reconstruction alone, Concomitant ACL and ALL reconstruction
Anterior Cruciate Ligament Tear Clinical Trial 2023: ACL Reconstruction Highlights & Side Effects. Trial Name: NCT04825587 — N/A
ACL Reconstruction (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04825587 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is participation in this research project being solicited?

"Yes, the data hosted on clinicaltrials.gov confirms that this research is actively seeking participants; it was initially posted on April 28th 2021 and most recently updated July 26th 2021. A total of 720 individuals from a single location are required for enrollment in the study."

Answered by AI

Are there vacancies to join this medical experiment?

"Data presented on clinicaltrials.gov shows that this medical trial is currently in progress and actively recruiting participants; the study's first posting was April 28th 2021, with a recent update occurring July 26th 2021."

Answered by AI
~293 spots leftby Apr 2026