Status:
COMPLETED
Prospective Study of Scheuermann's Kyphosis
Lead Sponsor:
Setting Scoliosis Straight Foundation
Collaborating Sponsors:
DePuy Spine
Conditions:
Scheuermann's Kyphosis
Eligibility:
All Genders
Up to 21 years
Brief Summary
The purpose of this study to determine the radiographic and clinical outcomes of spinal deformity surgical treatment in patients with Scheuermann's Kyphosis.
Eligibility Criteria
Inclusion
- 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.
- Inclusion Criteria for Anterior Release (for those surgeons performing anterior release surgery): Deformity magnitude = any degree and any other criteria defined by the individual surgeon.
- Posterior disc herniation is not an exclusion criteria from being in the study, only from being in the Posterior surgery group - these patients will be defaulted to Ant/Post Surgery.
- Only patients that have had a pre-op MRI performed as a part of their routine care, should be included in this study.
Exclusion
- Previous operated Kyphosis, Scoliosis or Spondylolisthesis
- Neuromuscular co-morbidity
- Post laminectomy kyphosis
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00738309
Start Date
May 1 2006
End Date
December 1 2013
Last Update
April 19 2016
Active Locations (9)
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1
UC Davis
Sacramento, California, United States, 95817
2
Rady Children's Hospital
San Diego, California, United States, 92123
3
A.I. DePont Hospital for Children
Wilmington, Delaware, United States, 19803
4
Miami Children's Hospital
Miami, Florida, United States, 33155