Pediatric ACL: Understanding Treatment Options
- Conditions
- Anterior Cruciate Ligament Reconstruction
- Interventions
- Other: Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions
- Registration Number
- NCT02772770
- Lead Sponsor
- Boston Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 765
- Diagnosis of complete intrasubstance ACL tear
- Skeletally Immature (by knee radiographs)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non Operative: Rehabilitation, Bracing, Activity Restriction Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Trial Locations
- Locations (10)
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States
Washington University at St. Louis
🇺🇸Saint Louis, Missouri, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Tennessee Orthopaedic Alliance
🇺🇸Nashville, Tennessee, United States