Clinical trial NCT02772770: Pediatric ACL: Understanding Treatment Options
Official title: Pediatric ACL: Understanding Treatment Options (PLUTO)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: Children's Hospital Medical Center, Cincinnati
name: Rady Children's Hospital, San Diego
name: Washington University School of Medicine
name: Children's Healthcare of Atlanta
name: The Cleveland Clinic
name: Tennessee Orthopedic Alliance
name: Hospital for Special Surgery, New York
name: Stanford University
First posted: 2016-05-16
Enrollment: 765
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The pool of patients for this study will be patients seen in outpatient and sports medicine clinics at each clinical center. The minimum accrual target for this study is 360 surgical patients and 45 non-operative patients

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.

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

Primary outcomes:
measure: Knee functional outcome at 2 years post-ACL reconstruction (Pedi-IKDC)
timeFrame: 2 years
Secondary outcomes:
measure: Health-related quality of life (Pediatric Quality of Life Inventory (PedsQL)
timeFrame: 2 years
measure: Graft failure (MRI, Lachman, Pivot-Shift)
timeFrame: 2 years
measure: Activity level (P-FABS and Physical Activity Questionnaire)
timeFrame: 2 years
measure: Growth disturbance (angular deformity, leg length discrepancy per clinical exam and radiographs)
timeFrame: 2 years
Other outcomes:
measure: Re-injury or instability requiring ACL reconstruction
timeFrame: 2 years
measure: Knee function (Pedi-IKDC)
timeFrame: 2 years
measure: Health-related quality of life (PedsQL)
timeFrame: 2 years
measure: Activity level ( P-FABS and Physical Activity Questionnaire)
timeFrame: 2 years
measure: Subsequent meniscal or chondral injury (MRI)
timeFrame: 2 years
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Orthopaedic Alliance
state: Tennessee
Study officials:
affiliation: Boston Children's Hospital
name: Mininder S Kocher, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: