Pediatric ACL: Understanding Treatment Options

Anterior Cruciate Ligament Reconstruction Clinical Trial

— PLUTO  

Official title:

Pediatric ACL: Understanding Treatment Options (PLUTO)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02772770
• Other study ID #: IRB-P00017850
• Status: Active, not recruiting
• Start date: September 2016
• Est. completion date: December 2030

Study information

• Verified date: August 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 765
• Est. completion date: December 2030
• Est. primary completion date: May 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

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.
• 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.
• 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).
• 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).

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Tennessee Orthopaedic Alliance	Nashville	Tennessee
United States	Hospital for Special Surgery	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Washington University at St. Louis	Saint Louis	Missouri
United States	Rady Children's Hospital	San Diego	California

Sponsors (10)

Lead Sponsor	Collaborator
Boston Children's Hospital	Children's Healthcare of Atlanta, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Hospital for Special Surgery, New York, Rady Children's Hospital, San Diego, Stanford University, Tennessee Orthopedic Alliance, The Cleveland Clinic, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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