Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-02 @ 2:50 AM
Study NCT ID:
NCT03384368
Status:
UNKNOWN
Last Update Posted:
2018-08-28
First Post:
2017-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Modified Placement of Two Additional Pedicle Screws at the Fracture Level for the Treatment of Thoracolumbar Burst Fractures--a Study Protocol of a Randomised Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-26', 'studyFirstSubmitDate': '2017-12-05', 'studyFirstSubmitQcDate': '2017-12-19', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compression ratio change of anterior border of vertebral body height', 'timeFrame': 'preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively', 'description': 'using X-ray fluorescence'}, {'measure': 'Depth of nail into injured vertebrae', 'timeFrame': 'at postoperation immediately', 'description': 'using X-ray fluorescence'}, {'measure': 'Kyphosis (Cobb) angle change', 'timeFrame': 'preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively', 'description': 'using X-ray fluorescence'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'right after surgery', 'description': 'Unit of Measure is hour'}, {'measure': 'intraoperative blood loss', 'timeFrame': 'right after surgery', 'description': 'Unit of Measure is ml'}, {'measure': 'Complications', 'timeFrame': 'at postoperation immediately, 1, 3 and 6 months, and at 1 and 2 years postoperatively.', 'description': 'Pedicle fractures, intraoperative pars fractures, postoperative infection, deep venous thrombosis, nerve injury, and any other direct or indirect surgical complications will be recorded.'}, {'measure': 'pain degree of back and lower limb', 'timeFrame': 'preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively.', 'description': 'The pain degree of back and lower limb during follow-up will be assessed by the VAS of back pain and VAS of leg pain'}, {'measure': 'Oswestry Disability Index (ODI) change', 'timeFrame': 'preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively', 'description': 'The Oswestry Disability Index (ODI) will be asssessed by questionnaire'}, {'measure': 'The Japanese Orthopaedic Association (JOA) scores', 'timeFrame': 'preoperatively and postoperatively including day 3 and then 1, 3, 6, 12 and 24 months', 'description': 'Functional improvement is expressed by the rate of recovery of the JOA scores'}, {'measure': 'The American Spinal Injury Association (ASIA) impairment scale', 'timeFrame': 'preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively', 'description': 'Spinal Injury was assessed using ASIA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Posterior Short-segment Pedicle Instrumentation']}, 'referencesModule': {'references': [{'pmid': '30696677', 'type': 'DERIVED', 'citation': 'Hu ZC, Li XB, Feng ZH, Wang JQ, Gong LF, Xuan JW, Fu X, Jiang BJ, Wu L, Ni WF. Modified pedicle screw placement at the fracture level for treatment of thoracolumbar burst fractures: a study protocol of a randomised controlled trial. BMJ Open. 2019 Jan 28;9(1):e024110. doi: 10.1136/bmjopen-2018-024110.'}]}, 'descriptionModule': {'briefSummary': 'Controversies exist about the best treatment of burst fractures of the thoracolumbar spine. Adding screws in fractured segment has been proved in many literatures that can improve construct stiffness but sometimes aggravate the trauma of fractured vertebra. Therefore, we are eager to find an optimized placement of two additional pedicle screws at the fracture level for the treatment of thoracolumbar burst fractures. This is the first randomised controlled study investigating efficacy of diverse orders of pedicle screws placement and will provide recommendations for treating patients with thoracolumbar burst fractures.', 'detailedDescription': 'A blinded randomised controlled trial (blinding for the patient and statistician, rather than for the clinician and researcher) will be conducted. A total of seventy patients with single thoracolumbar AO type A3 or A4 fractures who are candidates for application of short-segment pedicle screws of fractured vertebrae will be randomly allocated to either the DS group (distraction-screws ) or the SD group (screws-distraction) at a ratio of 1: 1. The primary clinical outcome measures are compression ratio of anterior border of vertebral body height, depth of nail into injured vertebrae and kyphosis (Cobb) angle. Secondary clinical outcome measures are complications, Visual Analogue Scale (VAS) of back and leg pain, neurological function, operating time, intraoperative blood loss, Japanese Orthopaedic Association (JOA) scores and Oswestry Disability Index. These parameters will be evaluated preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. 18 years of age or above.\n2. single thoracolumbar burst fractures\n3. AO type A3 or A4 fractures\n4. Thoracolumbar Injury Classification and Severity Score (TLICS) of more than 4 and duration of \\< 2 weeks\n5. application of posterior short-segment pedicle screws instrumentation at the fracture level Exclusion criteria\n\n1\\. previous pedicle instrumentation at the same level 2. multi-segmental thoracolumbar fractures or not AO type A3 or A4 are found 3. pregnancy 4. active infection or surgical site of the previous infection 5. planned emigration abroad within 2 years after inclusion 6. suffering from illness or long-term use of certain drugs affecting the stability of the spinal environment, such as metabolic bone disease, spinal tuberculosis and so on 7. the current use of anticoagulant (such as warfarin) or postoperative heparin for more than 6 months'}, 'identificationModule': {'nctId': 'NCT03384368', 'briefTitle': 'A Modified Placement of Two Additional Pedicle Screws at the Fracture Level for the Treatment of Thoracolumbar Burst Fractures--a Study Protocol of a Randomised Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'A Modified Placement of Two Additional Pedicle Screws at the Fracture Level for the Treatment of Thoracolumbar Burst Fractures--a Study Protocol of a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2017-08-115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Screw-Distraction (SD) group', 'description': 'six pedicle screws were implanted firstly, then distraction was achieved.', 'interventionNames': ['Device: fractured level screws-distraction']}, {'type': 'EXPERIMENTAL', 'label': 'Distraction-Screw (DS) group', 'description': 'four pedicle screws were implanted firstly, then distraction was achieved, two additional screws were introduced at the fracture level at last.', 'interventionNames': ['Device: fractured level screws-distraction']}], 'interventions': [{'name': 'fractured level screws-distraction', 'type': 'DEVICE', 'description': 'four pedicle screws were implanted into the upper vertebra and the lower vertebral body of the fractured vertebra. Then, immediate reduction and decompression were achieved by applying distraction of rod. Finally, two additional screws were introduced at fracture level', 'armGroupLabels': ['Distraction-Screw (DS) group', 'Screw-Distraction (SD) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'WENFEI NI', 'role': 'CONTACT'}], 'facility': "The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University", 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Wen-Fei Ni, Pro', 'role': 'CONTACT', 'email': 'wenfeini@yeah.net', 'phone': '86057788002814'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}