Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT01741168
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2012-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-30', 'studyFirstSubmitDate': '2012-11-22', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Roland Morris Disability Questionnaire', 'timeFrame': '3 months post fracture', 'description': 'The primary outcome measure is the Roland Morris Disability Questionnaire (RMDQ) administered at 3 months post fracture. The RMDQ evaluates physical disability secondary to low back pain and is validated, simple to administer, sensitive, and reliable. The questionnaire evaluates 24 items to derive a score that varies between zero (no disability) and twenty-four (severe disability). Three months was chosen because it is the time point at which we expect a significant functional recovery and readiness to resume most normal activities.'}], 'secondaryOutcomes': [{'measure': 'SF-36 physical component summary score', 'timeFrame': 'enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years'}, {'measure': 'SF-36 mental component summary score', 'timeFrame': 'enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years'}, {'measure': 'VAS pain score', 'timeFrame': 'enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months'}, {'measure': 'Satisfaction with Treatment', 'timeFrame': 'enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months', 'description': 'Overall satisfaction with treatment was assessed on a seven point scale, using the sentence, "All things considered, how satisfied are you with the results of your recent treatment for your spine fracture?" This is a recommended tool for assessing global satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thoracolumbar Burst Fractures Without Neurologic Deficit']}, 'descriptionModule': {'briefSummary': 'Braces have been used o treat stable (not requiring surgery) burst fractures with much success. Recently questions have been raised in regards to the importance of the brace. Some studies have results that suggest a brace is not important in having a good outcome. However, this has never been proven. This study is being conducted to see whether or not wearing a brace is important to having a good outcome.', 'detailedDescription': 'The purpose of this study is to prospectively compare the outcome between patients randomly assigned to a thoracolumbosacral orthosis (TLSO) treatment group or no orthosis (NO) treatment group, for the management of an acute AO type A3 thoracolumbar fracture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AO A3 burst fracture between T10 and L3 with associated kyphotic deformity \\<35 degrees\n* neurologically intact or isolated nerve root deficit\n* age 16-60 years\n* enrollment within 3 days of injury\n\nExclusion Criteria:\n\n* neurological deficit\n* can not comply with brace wearing (pregnancy/body mass index \\>40)\n* mobilized with or without a brace prior to recruitment\n* suffered a pathologic or open fracture\n* alcohol or drug abusers\n* had previous injury or surgery to the thoracolumbar region\n* unable to complete the questionnaires'}, 'identificationModule': {'nctId': 'NCT01741168', 'briefTitle': 'Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury', 'organization': {'class': 'OTHER', 'fullName': 'The London Spine Centre'}, 'officialTitle': 'TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial', 'orgStudyIdInfo': {'id': '11421'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TLSO', 'description': 'TLSO brace 8-10 weeks', 'interventionNames': ['Other: TLSO']}, {'type': 'EXPERIMENTAL', 'label': 'No Orthosis', 'description': 'No Orthosis', 'interventionNames': ['Other: No Orthosis']}], 'interventions': [{'name': 'TLSO', 'type': 'OTHER', 'otherNames': ['TLSO Aspen Medical Products, Irvine, CA, USA'], 'description': 'Patients in the TLSO arm will remain on bed rest until fitted with a TLSO. They will wear the TLSO for 8-10 weeks and mobilized in the brace by a physiotherapist.', 'armGroupLabels': ['TLSO']}, {'name': 'No Orthosis', 'type': 'OTHER', 'description': 'Patients in the No Orthosis group will be mobilized immediately as tolerated by a physiotherapist with restrictions to limit bending or rotating through their trunk. They will be encouraged to return to normal activities after 8 weeks.', 'armGroupLabels': ['No Orthosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Spine Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The London Spine Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}