Pediatric ACL: Understanding Treatment Options (PLUTO)

Boston Children's Hospital

Status: Active, not recruiting

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Procedure: Surgical technique: Partial transphyseal reconstruction; Procedure: Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher method; Procedure: Surgical technique: Physeal sparing reconstruction by the Anderson method; Other: Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions; Procedure: Surgical technique: Transphyseal reconstruction

Study type: Observational

Funder types: Other

Identifiers

NCT02772770

IRB-P00017850

Details and patient eligibility

About

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.

Full 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.

Enrollment: 765 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

765 participants in 5 patient groups

Non Operative: Rehabilitation, Bracing, Activity Restriction

Treatment:

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

Operative: Transphyseal

Treatment:

Procedure: Surgical technique: Transphyseal reconstruction

Operative: Partial Transphyseal

Treatment:

Procedure: Surgical technique: Partial transphyseal reconstruction

Operative: Physeal sparing by Anderson Technique

Treatment:

Procedure: Surgical technique: Physeal sparing reconstruction by the Anderson method

Operative: Physeal sparing by Micheli/Kocher Technique

Treatment:

Procedure: Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher method