Pediatric ACL: Understanding Treatment Options

Trial ID or NCT#

NCT02772770

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Pediatric ACL: Understanding Treatment Options (PLUTO)

Eligibility Criteria

Ages Eligible for Study: 5 to 18
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. * Diagnosis of complete intrasubstance ACL tear* Skeletally Immature (by knee radiographs)
    1. Exclusion Criteria:
  2. * 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
Exclusion Criteria:
  1. * 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
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Investigator(s)

Kevin Shea
Pediatric orthopaedic surgeon, Sports medicine surgeon
Chambers-Okamura Endowed Professor of Pediatric Orthopaedics

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Contact

Steven Frick, MD

View on ClinicalTrials.gov