Trial record 1 of 1 for:
NCT02049931
Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace
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ClinicalTrials.gov Identifier: NCT02049931 |
Recruitment Status :
Completed
First Posted : January 30, 2014
Results First Posted : May 25, 2015
Last Update Posted : August 7, 2018
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Sponsor:
Seoul National University Hospital
Information provided by (Responsible Party):
Jin S. Yeom, Seoul National University Hospital
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Tracking Information | ||||
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First Submitted Date ICMJE | January 28, 2014 | |||
First Posted Date ICMJE | January 30, 2014 | |||
Results First Submitted Date ICMJE | April 15, 2014 | |||
Results First Posted Date ICMJE | May 25, 2015 | |||
Last Update Posted Date | August 7, 2018 | |||
Study Start Date ICMJE | December 2012 | |||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Oswestry Disability Index (ODI) at 12 Weeks [ Time Frame: 12 weeks after injury ] The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).
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Original Primary Outcome Measures ICMJE |
Improvement of Oswestry Disability Index (ODI) [ Time Frame: 12 weeks after injury ] The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace | |||
Official Title ICMJE | The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace | |||
Brief Summary | The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace. | |||
Detailed Description | Bracing has been considered as a landmark step in conservative management for osteoporotic compression fractures. However, no prospective, randomized, and controlled clinical trials are available to document for the efficacy of wearing of the rigid or soft brace for the management of osteoporotic compression fracture. Therefore, the current trial was therefore designed to compare the outcome for improvement of disability and pain in patients with osteoporotic compression fracture using rigid, soft, or no brace. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Compression Fracture | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Kim HJ, Yi JM, Cho HG, Chang BS, Lee CK, Kim JH, Yeom JS. Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1959-66. doi: 10.2106/JBJS.N.00187. | |||
* 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 ICMJE | Completed | |||
Actual Enrollment ICMJE |
60 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2014 | |||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02049931 | |||
Other Study ID Numbers ICMJE | Brace001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Jin S. Yeom, Seoul National University Hospital | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Seoul National University Hospital | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Seoul National University Hospital | |||
Verification Date | August 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |