Pediatric ACL: Understanding Treatment Options

Pediatric ACL: Understanding Treatment Options (PLUTO)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02772770

Acronym

PLUTO

Enrollment

765

Registered

2016-05-16

Start date

2016-09-30

Completion date

2030-12-31

Last updated

2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

Brief 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.

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.

Interventions

OTHERNon-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions

The non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions.

PROCEDURESurgical technique: Transphyseal reconstruction

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.

PROCEDURESurgical technique: Partial transphyseal reconstruction

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.

PROCEDURESurgical technique: Physeal sparing reconstruction by the Anderson method

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).

PROCEDURESurgical technique: Physeal sparing reconstruction by the Micheli/Kocher method

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).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Knee functional outcome at 2 years post-ACL reconstruction (Pedi-IKDC)	2 years	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.

Secondary

Measure	Time frame	Description
Health-related quality of life (Pediatric Quality of Life Inventory (PedsQL)	2 years	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.
Graft failure (MRI, Lachman, Pivot-Shift)	2 years	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.
Activity level (P-FABS and Physical Activity Questionnaire)	2 years	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.
Growth disturbance (angular deformity, leg length discrepancy per clinical exam and radiographs)	2 years	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.

Other

Measure	Time frame	Description
Subsequent meniscal or chondral injury (MRI)	2 years	To establish outcomes associated with non-operative treatment (rehabilitation, bracing and activity restriction) used to manage complete intrasubstance ACL tears in pre- and early pubescent children.
Re-injury or instability requiring ACL reconstruction	2 years	To establish outcomes associated with non-operative treatment (rehabilitation, bracing and activity restriction) used to manage complete intrasubstance ACL tears in pre- and early pubescent children.
Knee function (Pedi-IKDC)	2 years	To establish outcomes associated with non-operative treatment (rehabilitation, bracing and activity restriction) used to manage complete intrasubstance ACL tears in pre- and early pubescent children.
Health-related quality of life (PedsQL)	2 years	To establish outcomes associated with non-operative treatment (rehabilitation, bracing and activity restriction) used to manage complete intrasubstance ACL tears in pre- and early pubescent children.
Activity level ( P-FABS and Physical Activity Questionnaire)	2 years	To establish outcomes associated with non-operative treatment (rehabilitation, bracing and activity restriction) used to manage complete intrasubstance ACL tears in pre- and early pubescent children.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026