| NCT ID | NCT04825587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago |
| Condition | ACL Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2021-04-28 |
| Primary Completion | 2030-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2021-04-28 with a primary completion date of 2030-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Neeraj Patel, MD
PRINCIPAL INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Frequently Asked Questions
Who can join the NCT04825587 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying ACL Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04825587 currently recruiting?
Yes, NCT04825587 is actively recruiting participants. Contact the research team at akass@luriechildrens.org for enrollment information.
Where is the NCT04825587 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT04825587 clinical trial?
NCT04825587 is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. The principal investigator is Neeraj Patel, MD at Ann & Robert H Lurie Children's Hospital of Chicago. The trial plans to enroll 240 participants.