PLUTO: Pediatric ACL: Understanding Treatment Options
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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).
|
Outcome Measures
Primary Outcome Measures
- Knee functional outcome at 2 years post-ACL reconstruction (Pedi-IKDC) [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
- Health-related quality of life (Pediatric Quality of Life Inventory (PedsQL) [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.
- Graft failure (MRI, Lachman, Pivot-Shift) [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.
- Activity level (P-FABS and Physical Activity Questionnaire) [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.
- Growth disturbance (angular deformity, leg length discrepancy per clinical exam and radiographs) [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
- Re-injury or instability requiring ACL reconstruction [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.
- Knee function (Pedi-IKDC) [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.
- Health-related quality of life (PedsQL) [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.
- Activity level ( P-FABS and Physical Activity Questionnaire) [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.
- Subsequent meniscal or chondral injury (MRI) [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University Medical Center | Palo Alto | California | United States | 94304 |
| 2 | Rady Children's Hospital | San Diego | California | United States | 92123 |
| 3 | Children's Healthcare of Atlanta | Atlanta | Georgia | United States | 30342 |
| 4 | Boston Children's Hospital | Boston | Massachusetts | United States | 02115 |
| 5 | Washington University at St. Louis | Saint Louis | Missouri | United States | 63130 |
| 6 | Hospital for Special Surgery | New York | New York | United States | 10021 |
| 7 | Cincinnati Children's Medical Center | Cincinnati | Ohio | United States | 45229 |
| 8 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 9 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 10 | Tennessee Orthopaedic Alliance | Nashville | Tennessee | United States | 37205 |
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
- Principal Investigator: Mininder S Kocher, MD, MPH, Boston Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-P00017850