Pediatric ACL: Understanding Treatment Options

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pediatric ACL: Understanding Treatment Options (PLUTO)

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non Operative: Rehabilitation, Bracing, Activity Restriction<br> | Other: Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions<br>* The non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions.<br>|
| Operative: Transphyseal<br> | Procedure: Surgical technique: Transphyseal reconstruction<br>* Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for transphyseal reconstruction with soft tissue graft and metaphyseal fixation.<br>|
| Operative: Partial Transphyseal<br> | Procedure: Surgical technique: Partial transphyseal reconstruction<br>* Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include partial transphyseal reconstruction (tibial transphyseal and femoral epiphyseal) with soft tissue graft.<br>|
| Operative: Physeal sparing by Anderson Technique<br> | Procedure: Surgical technique: Physeal sparing reconstruction by the Anderson method<br>* Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for physeal sparing epiphyseal reconstruction with soft tissue graft (Anderson technique).<br>|
| Operative: Physeal sparing by Micheli/Kocher Technique<br> | Procedure: Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher method<br>* Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include physeal-sparing with Iliotibial band combined extra-articular and intra-articular reconstructions (Micheli/Kocher Technique).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee functional outcome at 2 years post-ACL reconstruction (Pedi-IKDC) | To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life (Pediatric Quality of Life Inventory (PedsQL) | To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (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. | 2 years | 
| Graft failure (MRI, Lachman, Pivot-Shift) | To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (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. | 2 years | 
| Activity level (P-FABS and Physical Activity Questionnaire) | To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (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. | 2 years | 
| Growth disturbance (angular deformity, leg length discrepancy per clinical exam and radiographs) | To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (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. | 2 years |