Pediatric ACL: Understanding Treatment Options

Active, not recruitingOBSERVATIONAL
Enrollment

765

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

May 31, 2030

Study Completion Date

December 31, 2030

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).

Trial Locations (10)

10021

Hospital for Special Surgery, New York

19104

Children's Hospital of Philadelphia, Philadelphia

30342

Children's Healthcare of Atlanta, Atlanta

37205

Tennessee Orthopaedic Alliance, Nashville

44195

Cleveland Clinic Foundation, Cleveland

45229

Cincinnati Children's Medical Center, Cincinnati

63130

Washington University at St. Louis, St Louis

92123

Rady Children's Hospital, San Diego

94304

Stanford University Medical Center, Palo Alto

02115

Boston Children's Hospital, Boston

Sponsors
All Listed Sponsors
collaborator

Children's Hospital of Philadelphia

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Rady Children's Hospital, San Diego

OTHER

collaborator

Washington University School of Medicine

OTHER

collaborator

Children's Healthcare of Atlanta

OTHER

collaborator

The Cleveland Clinic

OTHER

collaborator

Tennessee Orthopedic Alliance

OTHER

collaborator

Hospital for Special Surgery, New York

OTHER

collaborator

Stanford University

OTHER

lead

Boston Children's Hospital

OTHER

NCT02772770 - Pediatric ACL: Understanding Treatment Options | Biotech Hunter | Biotech Hunter