Prospective Study of Scheuermann's Kyphosis
Completed
- Conditions
- Scheuermann's Kyphosis
- Registration Number
- NCT00738309
- Lead Sponsor
- Setting Scoliosis Straight Foundation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
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.
- 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 Criteria
- Previous operated Kyphosis, Scoliosis or Spondylolisthesis
- Neuromuscular co-morbidity
- Post laminectomy kyphosis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method radiographic outcomes 2 years
- Secondary Outcome Measures
Name Time Method Health related quality of life outcomes 2 years Clinical outcomes 2 years
Trial Locations
- Locations (9)
University Physicians
🇺🇸Camden, New Jersey, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Rehabilitationskrankenhaus Lagensteinbach
🇩🇪Lagensteinbach, Karlsbad, Germany
UC Davis
🇺🇸Sacramento, California, United States
A.I. DePont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Cincinnati Children's Hospital, Cincinnati, OH
🇺🇸Cincinnati, Ohio, United States
Shriners Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
John's Hopkins Medical Institute
🇺🇸Baltimore, Maryland, United States