Prospective Study of Scheuermann's Kyphosis (NCT00738309) | Clinical Trial Compass
CompletedNot Applicable
Prospective Study of Scheuermann's Kyphosis
United States, Germany147 participantsStarted 2006-05
Plain-language summary
The purpose of this study to determine the radiographic and clinical outcomes of spinal deformity surgical treatment in patients with Scheuermann's Kyphosis.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.