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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

Minimum Age

5 Years

Maximum Age

18 Years

Download Date

August 10, 2021

Principal Investigator

Mininder Kocher

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: