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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02827214
Registration number
NCT02827214
Ethics application status
Date submitted
23/05/2016
Date registered
11/07/2016
Date last updated
31/01/2023
Titles & IDs
Public title
Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment
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Scientific title
Thoracolumbar Burst Fractures (AOSpine A3, A4) in Neurologically Intact Patients: An Observational, Multicenter Cohort Study Comparing Surgical Versus Non-surgical Treatment
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Secondary ID [1]
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Spine_TL-A3-A4
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Thoracolumbar Burst Fracture
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Surgical treatment - Several surgical treatments exist to treat the fractures included in the study. The following section describes the different surgical treatment modalities in more detail
Approaches:
Open short segment surgical fixation (1 level above and below the fracture level) with or without posterior decompression
Open long segment posterior fixation (2 or more levels above, 2 or more levels below) with or without posterior decompression
Posterior short or long fixation with posterolateral corpectomy and reconstruction
Anterior alone instrumentation
Combined Anterior Posterior (AP) instrumentation
Percutaneous posterior fixation combined with anterior instrumentation
Percutaneous posterior fixation with or without vertebroplasty
Non-surgical treatment - Non-surgical treatment is defined as bed rest followed by immobilization with:
Custom-molded or prefabricated total body contact thoracolumbosacral orthosis (TLSO)
Thermoplastic removable brace
Jewett hyperextension braces
Anterior hyperextension brace (ASH)
Taylor-Knight brace
Plaster of Paris (POP)
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Oswestry Disability Index (ODI)
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Assessment method [1]
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ODI within the first year after surgical or non-surgical treatment using time to event analysis
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Timepoint [1]
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1 year
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Secondary outcome [1]
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AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost)
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Assessment method [1]
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AOSpine PROST consists of 19 questions on aspects of functioning such as personal care, traveling, and emotional functioning after the accident causing the spinal injury. Each item has a 0-100 numeric rating scale, supported by smileys at both ends of the ruler. It is important to realize that 0 indicates a level at which the patient is non-functional and 100 indicates the level before the accident, no matter how well or poorly the patient functioned before the accident.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Quality of life EQ5D-3L
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Assessment method [2]
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The EuroQoL-5D (EQ-5D) is a standardized instrument that was designed for self-completion. It has five items (mobility, self-care, usual activities, pain / discomfort and anxiety / depression) with a three-point categorical response scale (1 = no problems, 2 = some / moderate problems, 3 = extreme problems) where the patient's current health status will be assessed.
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Numeric Pain Rating Scale (NPRS)
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Assessment method [3]
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The NPRS measures the subjective intensity of pain. The patient is asked to make a pain rating, corresponding to his/her experienced pain.
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Spine Adverse Events Severity System (SAVES)
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Assessment method [4]
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The SAVES is a prospective adverse event (AE) recording instrument. The AEs are defined as any unexpected or undesirable events occurring as a result of spinal surgery, and a complication as a disease or disorder, which, as a consequence of a surgical procedure, that will negatively affect the outcome of a patient.
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Timepoint [4]
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2 years
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Secondary outcome [5]
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overall satisfaction with the treatment
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Assessment method [5]
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The overall satisfaction with treatment questionnaire contents one question regarding the satisfaction with the results of the recent treatment of the spine injury with a rating system from extremely satisfied (1) to not sure/no opinion (8)
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Non-surgical treatment failure rate
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Assessment method [6]
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Failure rate of conservative treatment will be assessed during this study. Non-surgical treatment failure is defined as necessity of surgery after non-surgical treatment.
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Surgical treatment failure rate
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Assessment method [7]
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Surgical treatment failure is defined as necessity of an additional surgery after the primary surgical treatment.
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Timepoint [7]
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2 years
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Secondary outcome [8]
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indirect cost questionnaire
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Assessment method [8]
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The indirect cost questionnaire assesses the personal situation of the patient at his workplace regarding to health, support, and their financial income statement
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Timepoint [8]
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2 years
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Secondary outcome [9]
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Validation of AO TL Classification System aided by the analysis of CT scans
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Assessment method [9]
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The participating clinics will upload the clinical data (de-identified X-rays, CT, MRI images) on a secure web-based platform. AOSpine Knowledge Forum Trauma Steering committee members, blinded to the diagnosis made in the study, will analyze the different images to validate the different TL fractures type A3 or A4 with or without PLC injury according to the new AOSpine TL Classification System.
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Timepoint [9]
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2 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2021
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Sample size
Target
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Accrual to date
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Final
213
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Alfred Health operating through the Alfred hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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New York
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Country [3]
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United States of America
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State/province [3]
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Pennsylvania
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Country [4]
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United States of America
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State/province [4]
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West Virginia
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Country [5]
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Canada
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State/province [5]
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Québec
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Country [6]
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Canada
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State/province [6]
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Vancouver
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Country [7]
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Egypt
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State/province [7]
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Assiut
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Country [8]
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Greece
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State/province [8]
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Kifisiá
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Country [9]
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India
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State/province [9]
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Coimbatore
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Country [10]
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Netherlands
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State/province [10]
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Utrecht
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Country [11]
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Romania
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State/province [11]
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Iasi
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Country [12]
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Spain
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State/province [12]
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Marbella
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Country [13]
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Switzerland
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State/province [13]
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Bern
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Funding & Sponsors
Primary sponsor type
Other
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Name
AO Innovation Translation Center
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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AO Foundation, AO Spine
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Thoracolumbar (TL) burst fractures in neurologically intact patients account for
approximately 45% of all TL spine injuries. Despite being common fractures, there is
significant variability in treatment recommendations encompassing surgery and non-surgical
treatment options. The controversy regarding optimal treatment for these injuries is fueled
by several studies which suggest a potential benefit to surgical treatment in the realm of
patient satisfaction, and the overall socio-economic burden of treatment while other studies
demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study
aims to perform a prospective cohort analysis investigating the clinical outcome of various
treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A
cost-effectiveness analysis will also be performed to identify costs and benefits of each
treatment option. More specifically a sub-group analysis will be performed for this group of
patients, which have equipoise in regards to patients treatment, as decided by a blinded
review panel.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02827214
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marcel Dvorak, MD
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Address
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Vancouver General Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02827214
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