Trial record 1 of 8 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 |
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 | |||||||||
* 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 | |||||||||
Current Responsible Party | Setting Scoliosis Straight Foundation | |||||||||
Original Responsible Party | Peter Newton, MD - Director of Harms Study Group, Children's Specialist Foundation | |||||||||
Current Study Sponsor | Setting Scoliosis Straight Foundation | |||||||||
Original Study Sponsor | Children's Specialists Foundation | |||||||||
Collaborators | DePuy Spine | |||||||||
Investigators |
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PRS Account | Setting Scoliosis Straight Foundation | |||||||||
Verification Date | April 2016 |