Pediatric ACL: Understanding Treatment Options

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.

Conditions

• Anterior Cruciate Ligament Reconstruction

Interventions

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.

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.

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.

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).

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).

Sponsors & Collaborators

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Rady Children's Hospital, San Diego

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Children's Healthcare of Atlanta

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Tennessee Orthopedic Alliance

  collaborator OTHER

• Hospital for Special Surgery, New York

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Mininder S Kocher, MD, MPH · Boston Children's Hospital

Eligibility

Min Age

5 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2030-05-31

Completion

2030-12-31

Countries

• United States

Study Locations