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Pediatric ACL: Understanding Treatment Options (PLUTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02772770
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : July 9, 2019
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Rady Children's Hospital, San Diego
Washington University School of Medicine
Children's Healthcare of Atlanta
The Cleveland Clinic
Tennessee Orthopedic Alliance
Hospital for Special Surgery, New York
Stanford University
Information provided by (Responsible Party):
Mininder Kocher, 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.

Condition or disease Intervention/treatment
Anterior Cruciate Ligament Reconstruction 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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric ACL: Understanding Treatment Options (PLUTO)
Actual Study Start Date : September 2016
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Knee functional outcome at 2 years post-ACL reconstruction (Pedi-IKDC) [ Time Frame: 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 :
  1. Health-related quality of life (Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 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.

  2. Graft failure (MRI, Lachman, Pivot-Shift) [ Time Frame: 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.

  3. Activity level (P-FABS and Physical Activity Questionnaire) [ Time Frame: 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.

  4. Growth disturbance (angular deformity, leg length discrepancy per clinical exam and radiographs) [ Time Frame: 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.


Other Outcome Measures:
  1. Re-injury or instability requiring ACL reconstruction [ Time Frame: 2 years ]
    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. Knee function (Pedi-IKDC) [ Time Frame: 2 years ]
    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.

  3. Health-related quality of life (PedsQL) [ Time Frame: 2 years ]
    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.

  4. Activity level ( P-FABS and Physical Activity Questionnaire) [ Time Frame: 2 years ]
    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.

  5. Subsequent meniscal or chondral injury (MRI) [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772770


Contacts
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Contact: Lauren E Hutchinson, MPH 617-919-1632 ext x91632 Lauren.Hutchinson@childrens.harvard.edu

Locations
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United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Anthony Chen       achen24@stanford.edu   
Principal Investigator: Kevin Shea, MD         
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Alyssa Carroll       ACarroll1@rchsd.org   
Sub-Investigator: Hank Chambers, MD         
Sub-Investigator: Andrew Pennock, MD         
Principal Investigator: Eric Edmonds, MD         
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Contact: Asahi Murata       asahi.murata@choa.org   
Principal Investigator: Clinton Willimon, MD         
Sub-Investigator: Michael Busch, MD         
Sub-Investigator: Chrystal Perkins, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lauren E Hutchinson, MPH    617-919-1632    Lauren.Hutchinson@childrens.harvard.edu   
Sub-Investigator: Benton Heyworth, MD         
Sub-Investigator: Lyle Micheli, MD         
Sub-Investigator: Matthew Milewksi, MD         
Principal Investigator: Mininder Kocher, MD, MPH         
Sub-Investigator: Melissa Christino, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Wendy Holloway       wendyholloway@wustl.edu   
Contact: Zak Robben       zachary.robben@wustl.edu   
Principal Investigator: Jeffrey J Nepple, MD         
Sub-Investigator: Matthew Matava, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Hunter Aitchison       aitchisona@hss.edu   
Contact: Madison Heath       heathm@HSS.EDU   
Sub-Investigator: Peter D Fabricant, MD         
Sub-Investigator: Frank A Cordasco, MD         
Principal Investigator: Daniel W Greene, MD         
United States, Ohio
Cincinnati Children's Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Matthew Veerkamp       Matthew.Veerkamp@cchmc.org   
Principal Investigator: Eric Wall, MD         
Sub-Investigator: Shital Parikh, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jennifer Turczyj       turczyj@ccf.org   
Principal Investigator: Paul M Saluan, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Julien Aoyama       AoyamaJ@email.chop.edu   
Sub-Investigator: Todd Lawrence, MD         
Principal Investigator: Theodore Ganley, MD         
United States, Tennessee
Tennessee Orthopaedic Alliance Recruiting
Nashville, Tennessee, United States, 37205
Contact: Janet Trimble    615-234-7217    trimblejt@toa.com   
Principal Investigator: Christian F Anderson, MD         
Sponsors and Collaborators
Boston Children’s Hospital
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Rady Children's Hospital, San Diego
Washington University School of Medicine
Children's Healthcare of Atlanta
The Cleveland Clinic
Tennessee Orthopedic Alliance
Hospital for Special Surgery, New York
Stanford University
Investigators
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Principal Investigator: Mininder S Kocher, MD, MPH Boston Children’s Hospital

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Responsible Party: Mininder Kocher, Principal Investigator, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02772770    
Other Study ID Numbers: IRB-P00017850
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No