Pediatric ACL: Understanding Treatment Options (PLUTO)

Pediatric ACL: Understanding Treatment Options (PLUTO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anterior Cruciate Ligament Reconstruction
• Intervention / Treatment: 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

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.

• Study Type: Observational
• Enrollment (Actual): 765

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Healthcare of Atlanta
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University at St. Louis
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Tennessee Orthopaedic Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non Operative: Rehabilitation, Bracing, Activity Restriction	Other: Non-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.
Operative: Transphyseal	Procedure: Surgical 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.
Operative: Partial Transphyseal	Procedure: Surgical 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.
Operative: Physeal sparing by Anderson Technique	Procedure: Surgical 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).
Operative: Physeal sparing by Micheli/Kocher Technique	Procedure: Surgical 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).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-injury or instability requiring ACL reconstruction	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.	2 years
Knee function (Pedi-IKDC)	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.	2 years
Health-related quality of life (PedsQL)	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.	2 years
Activity level ( P-FABS and Physical Activity Questionnaire)	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.	2 years
Subsequent meniscal or chondral injury (MRI)	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.	2 years

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Children's Hospital of Philadelphia; Washington University School of Medicine; The Cleveland Clinic; Stanford University; Children's Hospital Medical Center, Cincinnati; Hospital for Special Surgery, New York; Children's Healthcare of Atlanta; Rady Children's Hospital, San Diego; Tennessee Orthopedic Alliance
• Investigators: Principal Investigator: Mininder S Kocher, MD, MPH, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (Estimated): May 16, 2016

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB-P00017850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO