Summary
Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature patients.
Conditions
Anterior Cruciate Ligament Reconstruction
Recruitment Status
ACTIVE_NOT_RECRUITING
Detailed Description
Anterior Cruciate Ligament (ACL) injuries are being seen with increased frequency in pediatric and adolescent patients. The management of these injuries is controversial and includes nonoperative treatment and operative treatment with various surgical techniques. Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature patients. Accrual will take place over eight years at 9 pediatric sports medicine centers. Post-treatment outcome assessment will be performed at 6-9 months, 1 year, and 2, 5, and 10 years after treatment , including functional outcome, activity level, health-related quality of life, graft survivorship, knee stability, knee motion, and growth disturbance.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of complete intrasubstance ACL tear
* Skeletally Immature (by knee radiographs)
Exclusion Criteria:
* Prior ACL surgery on the ipsilateral knee
* Congenital ACL deficiency
* Multiple ligament reconstruction required
* Other significant comorbidities including syndromic conditions, neuromuscular disorders or developmental delay
* If scheduling of the ACL surgery is impacted by the skeletal maturity of the patient
* Simultaneous bilateral ACL tears
Intervention
Intervention Type
Intervention Name
OTHER
Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions
PROCEDURE
Surgical technique: Transphyseal reconstruction
PROCEDURE
Surgical technique: Partial transphyseal reconstruction
PROCEDURE
Surgical technique: Physeal sparing reconstruction by the Anderson method
PROCEDURE
Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher method
Gender
ALL
Min Age
5 Years
Max Age
18 Years
Download Date
2023-08-14
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: