Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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13 February 2023 |
Main ID: |
NCT02827214 |
Date of registration:
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23/05/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment
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Scientific title:
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Thoracolumbar Burst Fractures (AOSpine A3, A4) in Neurologically Intact Patients: An Observational, Multicenter Cohort Study Comparing Surgical Versus Non-surgical Treatment |
Date of first enrolment:
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October 2016 |
Target sample size:
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213 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02827214 |
Study type:
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Observational |
Study design:
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Phase:
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Countries of recruitment
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Australia
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Canada
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Egypt
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Greece
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India
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Netherlands
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Qatar
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Romania
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Spain
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Switzerland
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Turkey
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United States
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Contacts
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Name:
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Marcel Dvorak, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Vancouver General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Skeletally mature, age 18 to 65 years old inclusive
- Diagnosis of AO type A3 or A4 fractures on a CT scan with or without a suspected PLC
injury (M1) from T10 to L2.
- Patients may have an associated B injury, but must have an A3 or A4.
- TLICS Score between 2-5 inclusive
- Acute fracture - diagnosis and treatment within 10 days of injury
- Ability to understand the content of the patient information / informed consent form
- Willingness and ability to participate in the clinical investigation including imaging
and FU procedures
- Investigation according to the Clinical Investigation Plan (CIP)
- Signed and dated IRB/EC-approved written informed consent
Exclusion Criteria:
- Any neurological deficit associated with the fracture. Absence of neurological deficit
will be determined with the International Standards for Neurological Classification of
Spinal Cord Injury (ISNC SCI). It will be documented the status "E" (neurologically
intact/normal) of the patient.
- Spontaneous fractures due to pathologic processes or neoplasia
- Head injuries causing inability to cooperate during hospital admission
- Open or penetrating spinal lesion (e.g. due to gun, stab, or projectile)
- Prior spinal surgeries in thoracic or lumbar spine
- Additional musculoskeletal, head or other injuries which would preclude rapid
mobilization
- Multiple trauma or Injury Severity Score (ISS) > 16
- Other co-morbidities precluding the patient to be considered as a surgical or
non-surgical candidate, i.e. burns, dementia, BMI > 40, etc.
- Any severe systemic medical disease that would exclude the patient to be a potential
candidate for surgery
- Prisoner
- Participation in any other medical device or medicinal product study within the
previous month that could influence the results of the present study
- Recent history of substance abuse (i.e., recreational drugs, alcohol) that would
preclude reliable assessment.
- Pregnancy or women planning to conceive within the study period
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Thoracolumbar Burst Fracture
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Primary Outcome(s)
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Oswestry Disability Index (ODI)
[Time Frame: 1 year]
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Secondary Outcome(s)
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Validation of AO TL Classification System aided by the analysis of CT scans
[Time Frame: 2 years]
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Non-surgical treatment failure rate
[Time Frame: 2 years]
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Quality of life EQ5D-3L
[Time Frame: 2 years]
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AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost)
[Time Frame: 2 years]
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indirect cost questionnaire
[Time Frame: 2 years]
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Numeric Pain Rating Scale (NPRS)
[Time Frame: 2 years]
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Spine Adverse Events Severity System (SAVES)
[Time Frame: 2 years]
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overall satisfaction with the treatment
[Time Frame: 2 years]
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Surgical treatment failure rate
[Time Frame: 2 years]
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Secondary ID(s)
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Spine_TL-A3-A4
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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