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NCT02772770 · ClinicalTrials.gov registry record
Pediatric ACL: Understanding Treatment Options
A clinical trial of Anterior Cruciate Ligament Reconstruction, sponsored by Boston Children's Hospital.
- Active
- Registry status
- 765
- Enrollment target
- 10
- Study locations
NCT02772770: Active study of Anterior Cruciate Ligament Reconstruction, sponsored by Boston Children's Hospital.
NCT02772770 is a study of Anterior Cruciate Ligament Reconstruction that is active but no longer recruiting, run by Boston Children's Hospital. The registered enrollment target is 765 participants, above the 225-participant average among 11 other Anterior Cruciate Ligament Reconstruction trials with a reported enrollment target (240% higher). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02772770, a study of Anterior Cruciate Ligament Reconstruction, is active but no longer recruiting, sponsored by Boston Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 765 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- 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
Study Locations (10)
California
- Stanford University Medical Center - Palo Alto
- Rady Children's Hospital - San Diego
Ohio
- Cincinnati Children's Medical Center - Cincinnati
- Cleveland Clinic Foundation - Cleveland
Georgia
- Children's Healthcare of Atlanta - Atlanta
Massachusetts
- Boston Children's Hospital - Boston
Missouri
- Washington University at St. Louis - St Louis
New York
- Hospital for Special Surgery - New York
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Tennessee
- Tennessee Orthopaedic Alliance - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 765 participants |
| Start Date | 2016-09 |
| Est. Completion | 2030-12 |
What the registry record for NCT02772770 still lists
NCT02772770 is an observational study that tracks outcomes without assigning an intervention. The registered 765 participants enrollment target is mid-sized for trials with a published cap, above the 225-participant average among 11 other Anterior Cruciate Ligament Reconstruction trials with a reported enrollment target (240% higher).
The record links to 1 condition, with Anterior Cruciate Ligament Reconstruction appearing as the primary indexed condition, and to 5 interventions - of which Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions is the first listed.
NCT02772770 lists 10 locations in 8 states (California, Ohio, Georgia).
Frequently Asked Questions
What is clinical trial NCT02772770 about?
NCT02772770 is a clinical study titled "Pediatric ACL: Understanding Treatment Options". 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) part...
What is the current status of trial NCT02772770?
This trial is currently active not recruiting. The enrollment target is 765 participants. The study started on 2016-09. Estimated completion is 2030-12.
What conditions does trial NCT02772770 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Reconstruction.
What interventions are being tested in trial NCT02772770?
The interventions under investigation include: Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions (OTHER), 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 (PROCEDURE).
Who is sponsoring clinical trial NCT02772770?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02772770 being conducted?
This trial has 10 study locations across California, Georgia, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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