Status:
RECRUITING
The Pediatric ALL Evaluation and Trial
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsors:
Children's Hospital of Philadelphia
Texas Children's
Conditions:
ACL Injury
ACL Tear
Eligibility:
All Genders
Up to 18 years
Phase:
NA
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...
Detailed Description
Studies have reported a rising incidence of anterior cruciate ligament (ACL) injuries in children and adolescents. Beck et al reported a 2.3% annual increase between 1994 and 2013. In New York State, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04825587
Start Date
April 28 2021
End Date
April 1 2028
Last Update
November 15 2024
Active Locations (1)
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1
Lurie Children's Hospital
Chicago, Illinois, United States, 60611