Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
147 participants
OBSERVATIONAL
2006-05-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Operative
Diagnosis of classical Scheuermann's Kyphosis (3 successive vertebrae wedged 5 degrees or more, +/- end plate deformities) or idiopathic structural Kyphosis (rigid structural kyphosis without classic Scheuermann's Kyphosis findings) for which surgical treatment is recommended to prevent progression of the curvature or to correct trunk deformity (unacceptable cosmesis).
No interventions assigned to this group
Non-operative
Diagnosis of classical Scheuermann's Kyphosis (3 successive vertebrae wedged 5 degrees or more, +/- end plate deformities) or idiopathic structural Kyphosis (rigid structural kyphosis without classic Scheuermann's Kyphosis findings) for which surgical treatment was not undertaken.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Male or female
* Diagnosis of classical Scheuermann's Kyphosis (3 successive vertebrae wedged 5 degrees or more, +/- end plate deformities) or idiopathic structural Kyphosis (rigid structural kyphosis without classic Scheuermann's Kyphosis findings).
* for which surgical treatment is recommended to prevent progression of the curvature or to correct trunk deformity (unacceptable cosmesis) - any deformity magnitude.
OR
* for which surgical treatment is not being undertaken (and alternate treatment, i.e. bracing, or observation) is being pursued for any curve magnitude of clinical concerns of Scheuermann's Kyphosis.
Exclusion Criteria
* Previous operated Kyphosis, Scoliosis or Spondylolisthesis
* Neuromuscular co-morbidity
* Post laminectomy kyphosis
21 Years
ALL
No
Sponsors
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DePuy Spine
INDUSTRY
Setting Scoliosis Straight Foundation
OTHER
Responsible Party
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Principal Investigators
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Baron Lonner, MD
Role: PRINCIPAL_INVESTIGATOR
Scoliosis Associates - New York, NY
Peter Newton, MD
Role: STUDY_DIRECTOR
Rady Children's Hospital, San Diego
Michelle C Marks, PT, MA
Role: STUDY_CHAIR
Harms Study Group
Locations
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UC Davis
Sacramento, California, United States
Rady Children's Hospital
San Diego, California, United States
A.I. DePont Hospital for Children
Wilmington, Delaware, United States
Miami Children's Hospital
Miami, Florida, United States
John's Hopkins Medical Institute
Baltimore, Maryland, United States
University Physicians
Camden, New Jersey, United States
Cincinnati Children's Hospital, Cincinnati, OH
Cincinnati, Ohio, United States
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States
Rehabilitationskrankenhaus Lagensteinbach
Lagensteinbach, Karlsbad, Germany
Countries
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Other Identifiers
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2006HSGDEF13
Identifier Type: -
Identifier Source: org_study_id
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