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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Rady Children's Hospital, San Diego | OTHER |
| Washington University School of Medicine |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non Operative: Rehabilitation, Bracing, Activity Restriction |
| ||
| Operative: Transphyseal |
| ||
| Operative: Partial Transphyseal |
| ||
| Operative: Physeal sparing by Anderson Technique |
| ||
| Operative: Physeal sparing by Micheli/Kocher Technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions | Other | The non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Knee function (Pedi-IKDC) |
Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Mininder S Kocher, MD, MPH | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94304 | United States | ||
| Rady Children's Hospital |
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| OTHER |
| Children's Healthcare of Atlanta | OTHER |
| The Cleveland Clinic | OTHER |
| Tennessee Orthopedic Alliance | OTHER |
| Hospital for Special Surgery, New York | OTHER |
| Stanford University | OTHER |
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| Surgical technique: Transphyseal reconstruction | Procedure | 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 | Procedure | 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 | Procedure | 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 | Procedure | 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). |
|
| 2 years |
| 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 |
| 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 |
| 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 |
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 |
| 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 |
| 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 |
| 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 |
| San Diego |
| California |
| 92123 |
| United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30342 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University at St. Louis | St Louis | Missouri | 63130 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Tennessee Orthopaedic Alliance | Nashville | Tennessee | 37205 | United States |
| ID | Term |
|---|---|
| D001915 | Braces |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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