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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02827214
Ethics application status
Date submitted
23/05/2016
Date registered
11/07/2016

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)
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost)
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Quality of life EQ5D-3L
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Numeric Pain Rating Scale (NPRS)
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Spine Adverse Events Severity System (SAVES)
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
overall satisfaction with the treatment
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Non-surgical treatment failure rate
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Surgical treatment failure rate
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
indirect cost questionnaire
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Validation of AO TL Classification System aided by the analysis of CT scans
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2021
Sample size
Target
Accrual to date
Final
213
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
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
West Virginia
Country [5] 0 0
Canada
State/province [5] 0 0
Québec
Country [6] 0 0
Canada
State/province [6] 0 0
Vancouver
Country [7] 0 0
Egypt
State/province [7] 0 0
Assiut
Country [8] 0 0
Greece
State/province [8] 0 0
Kifisiá
Country [9] 0 0
India
State/province [9] 0 0
Coimbatore
Country [10] 0 0
Netherlands
State/province [10] 0 0
Utrecht
Country [11] 0 0
Romania
State/province [11] 0 0
Iasi
Country [12] 0 0
Spain
State/province [12] 0 0
Marbella
Country [13] 0 0
Switzerland
State/province [13] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Other
Name
AO Innovation Translation Center
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02827214