Pediatric ACL: Understanding Treatment Options



Status:Recruiting
Healthy:No
Age Range:5 - 16
Updated:1/18/2019
Start Date:September 2016
End Date:December 2026
Contact:Lauren E Hutchinson, MPH
Email:Lauren.Hutchinson@childrens.harvard.edu
Phone:617-919-1632

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Pediatric ACL: Understanding Treatment Options (PLUTO)

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.

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
We found this trial at
10
sites
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-919-1632
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Clinton Willimon, MD
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, GA
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Cincinnati, Ohio 45267
Principal Investigator: Eric Wall, MD
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Cincinnati, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Paul M Saluan, MD
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Nashville, Tennessee 37205
Principal Investigator: Christian F Anderson, MD
Phone: 615-234-7217
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Nashville, TN
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535 E 70th St
New York, New York 10021
(212) 606-1000
Phone: 212-606-1631
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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Palo Alto, California 94304
Principal Investigator: Kevin Shea, MD
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Saint Louis, Missouri 63110
Principal Investigator: Jeffrey J Nepple, MD
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San Diego, California 92123
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San Diego, CA
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