Trial record 1 of 6 for:
"Scheuermann Disease"
Prospective Study of Scheuermann's Kyphosis (PSK)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00738309 |
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Recruitment Status :
Completed
First Posted : August 20, 2008
Last Update Posted : April 19, 2016
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Sponsor:
Setting Scoliosis Straight Foundation
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
Setting Scoliosis Straight Foundation
| Tracking Information | ||||||||||
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| First Submitted Date | August 18, 2008 | |||||||||
| First Posted Date | August 20, 2008 | |||||||||
| Last Update Posted Date | April 19, 2016 | |||||||||
| Study Start Date | May 2006 | |||||||||
| Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
radiographic outcomes [ Time Frame: 2 years ] | |||||||||
| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Prospective Study of Scheuermann's Kyphosis | |||||||||
| Official Title | Prospective Study of Scheuermann's Kyphosis | |||||||||
| 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 Provided | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study. | |||||||||
| Condition | Scheuermann's Kyphosis | |||||||||
| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
147 | |||||||||
| Original Estimated Enrollment |
240 | |||||||||
| Actual Study Completion Date | December 2013 | |||||||||
| Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
OR
Exclusion Criteria:
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| Sex/Gender |
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| Ages | up to 21 Years (Child, Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Germany, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT00738309 | |||||||||
| Other Study ID Numbers | 2006HSGDEF13 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Setting Scoliosis Straight Foundation | |||||||||
| Study Sponsor | Setting Scoliosis Straight Foundation | |||||||||
| Collaborators | DePuy Spine | |||||||||
| Investigators |
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| PRS Account | Setting Scoliosis Straight Foundation | |||||||||
| Verification Date | April 2016 | |||||||||