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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02827214




Registration number
NCT02827214
Ethics application status
Date submitted
23/05/2016
Date registered
11/07/2016
Date last updated
5/07/2019

Titles & IDs
Public title
Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment
Scientific title
Thoracolumbar Burst Fractures (AOSpine A3, A4) in Neurologically Intact Patients: An Observational, Multicenter Cohort Study Comparing Surgical Versus Non-surgical Treatment
Secondary ID [1] 0 0
Spine_TL-A3-A4
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thoracolumbar Burst Fracture 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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)

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Oswestry Disability Index (ODI) - ODI within the first year after surgical or non-surgical treatment using time to event analysis
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost) - 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.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Quality of life EQ5D-3L - 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.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Numeric Pain Rating Scale (NPRS) - The NPRS measures the subjective intensity of pain. The patient is asked to make a pain rating, corresponding to his/her experienced pain.
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Spine Adverse Events Severity System (SAVES) - 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.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
overall satisfaction with the treatment - 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)
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Non-surgical treatment failure rate - 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.
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Surgical treatment failure rate - Surgical treatment failure is defined as necessity of an additional surgery after the primary surgical treatment.
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
indirect cost questionnaire - The indirect cost questionnaire assesses the personal situation of the patient at his workplace regarding to health, support, and their financial income statement
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Validation of AO TL Classification System aided by the analysis of CT scans - 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.
Timepoint [9] 0 0
2 years

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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Health operating through the Alfred hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
United States of America
State/province [6] 0 0
West Virginia
Country [7] 0 0
Canada
State/province [7] 0 0
Québec
Country [8] 0 0
Canada
State/province [8] 0 0
Vancouver
Country [9] 0 0
Egypt
State/province [9] 0 0
Assiut
Country [10] 0 0
Greece
State/province [10] 0 0
Kifisiá
Country [11] 0 0
India
State/province [11] 0 0
Coimbatore
Country [12] 0 0
Netherlands
State/province [12] 0 0
Utrecht
Country [13] 0 0
Qatar
State/province [13] 0 0
Doha
Country [14] 0 0
Romania
State/province [14] 0 0
Iasi
Country [15] 0 0
Spain
State/province [15] 0 0
Marbella
Country [16] 0 0
Switzerland
State/province [16] 0 0
Bern
Country [17] 0 0
Turkey
State/province [17] 0 0
Nilufer

Funding & Sponsors
Primary sponsor type
Other
Name
AO Clinical Investigation and Documentation
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
AO Foundation, AO Spine
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02827214
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marcel Dvorak, MD
Address 0 0
Vancouver General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Brigitte S. Gallo-Kopf, PhD
Address 0 0
Country 0 0
Phone 0 0
+41 44 200 24 06
Fax 0 0
Email 0 0
brigitte.gallo@aofoundation.org
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02827214