Prospective Study of Scheuermann's Kyphosis

NCT ID: NCT00738309

Last Updated: 2016-04-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study to determine the radiographic and clinical outcomes of spinal deformity surgical treatment in patients with Scheuermann's Kyphosis.

Detailed Description

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Conditions

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Scheuermann's Kyphosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* Patient age \< 21 years
* 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

* Only patients that have had a pre-op MRI performed as a part of their routine care, should be included in this study.


* Previous operated Kyphosis, Scoliosis or Spondylolisthesis
* Neuromuscular co-morbidity
* Post laminectomy kyphosis
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Spine

INDUSTRY

Sponsor Role collaborator

Setting Scoliosis Straight Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Rady Children's Hospital

San Diego, California, United States

Site Status

A.I. DePont Hospital for Children

Wilmington, Delaware, United States

Site Status

Miami Children's Hospital

Miami, Florida, United States

Site Status

John's Hopkins Medical Institute

Baltimore, Maryland, United States

Site Status

University Physicians

Camden, New Jersey, United States

Site Status

Cincinnati Children's Hospital, Cincinnati, OH

Cincinnati, Ohio, United States

Site Status

Shriners Hospital for Children

Philadelphia, Pennsylvania, United States

Site Status

Rehabilitationskrankenhaus Lagensteinbach

Lagensteinbach, Karlsbad, Germany

Site Status

Countries

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United States Germany

Other Identifiers

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2006HSGDEF13

Identifier Type: -

Identifier Source: org_study_id

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