The Pediatric ALL Evaluation and Trial (NCT04825587) | Clinical Trial Compass
RecruitingNot Applicable
The Pediatric ALL Evaluation and Trial
United States240 participantsStarted 2021-04-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Graft failure
Timeframe: Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
Trial details
NCT IDNCT04825587
SponsorAnn & Robert H Lurie Children's Hospital of Chicago