- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02827214
Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment
January 6, 2023 updated by: AO Innovation Translation Center
Thoracolumbar Burst Fractures (AOSpine A3, A4) in Neurologically Intact Patients: An Observational, Multicenter Cohort Study Comparing Surgical Versus Non-surgical Treatment
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.
Study Overview
Status
Completed
Conditions
Detailed Description
208 subjects (i.e., 137 per surgical group; 71 per conservative group) with TL burst fractures AOSpine classification type A3 or A4 without neurological deficit as defined in the inclusion/exclusion criteria, and with or without suspected Posterior Ligament Complex (PLC) injury (M1) from T10 to L2, will be enrolled in a prospective multicenter cohort study.
Patients may have an associated B injury, but must have an A3 or A4.
Patients will be monitored prospectively for patient reported, clinical and radiologic outcomes, over a period of 2 years post-treatment.
Specifically a patient diary will measure the Oswestry Disability Index (ODI), and employment information (indirect costs questionnaire) every second week until 6 months post-treatment.
Diary will continue every second month until 2 years post-treatment.
All interventions/examinations are considered as standard of care.
Study Type
Observational
Enrollment (Actual)
213
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Melbourne, Australia, 3004
- Alfred Health operating through the Alfred hospital
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Québec, Canada, 1401
- Hopital l'Enfant-Jesus, CHU de Quebec
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Vancouver, Canada, V5z1M9
- Vancouver General Hospital
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Assiut, Egypt, 71526
- Assiut university hospitals
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Kifisiá, Greece, 145 61
- KAT Hospital
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Coimbatore, India, 641011
- Ganga Hospital
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Utrecht, Netherlands, 3508 AB
- UMC Utrecht
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Iasi, Romania
- Clinical Hospital "Prof. N.Oblu"
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Marbella, Spain, 29603
- Hospital Universitario Costa Del Sol
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Bern, Switzerland, 3010
- Inselspital, University of Bern
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California
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San Diego, California, United States, 92093
- University of California, San Diego Medical Center
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New York
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East Syracuse, New York, United States, 13057
- SUNY Upstate
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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West Virginia
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Morgantown, West Virginia, United States, 26506-9496
- West Virginia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with thoracolumbar burst fractures
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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:
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Non-surgical treatment
Non-surgical treatment is defined as bed rest followed by immobilization with:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Oswestry Disability Index (ODI)
Time Frame: 1 year
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ODI within the first year after surgical or non-surgical treatment using time to event analysis
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost)
Time Frame: 2 years
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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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2 years
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Quality of life EQ5D-3L
Time Frame: 2 years
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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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2 years
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Numeric Pain Rating Scale (NPRS)
Time Frame: 2 years
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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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2 years
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Spine Adverse Events Severity System (SAVES)
Time Frame: 2 years
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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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2 years
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overall satisfaction with the treatment
Time Frame: 2 years
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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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2 years
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Non-surgical treatment failure rate
Time Frame: 2 years
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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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2 years
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Surgical treatment failure rate
Time Frame: 2 years
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Surgical treatment failure is defined as necessity of an additional surgery after the primary surgical treatment.
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2 years
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indirect cost questionnaire
Time Frame: 2 years
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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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2 years
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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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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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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marcel Dvorak, MD, Vancouver General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
May 23, 2016
First Submitted That Met QC Criteria
July 7, 2016
First Posted (Estimate)
July 11, 2016
Study Record Updates
Last Update Posted (Estimate)
January 9, 2023
Last Update Submitted That Met QC Criteria
January 6, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Spine_TL-A3-A4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thoracolumbar Burst Fracture
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Uppsala UniversityKarolinska University Hospital; Karolinska Institutet; Oslo University Hospital; Sahlgrenska University Hospital, Sweden and other collaboratorsRecruiting
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Jinling Hospital, ChinaNational Natural Science Foundation of ChinaUnknownThoracolumbar Burst FractureChina
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Insel Gruppe AG, University Hospital BernRecruitingSPINAL Fracture | Burst Fracture | Spinal Instability of Thoracolumbar RegionSwitzerland
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Sklifosovsky Institute of Emergency CareRecruitingSpine Fusion | Spine Fracture | Thoracic Spine Fracture | Thoracolumbar Burst Fracture | Lumbar; Spine, Fracture | Fracture of Spine, Level UnspecifiedRussian Federation
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The London Spine CentreCompletedThoracolumbar Burst Fractures Without Neurologic DeficitCanada
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Taipei Veterans General Hospital, TaiwanCompletedBurst FractureTaiwan
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St. Louis UniversityTerminatedCompression Fracture of Thoracic Vertebral Body | Thoracic Fracture | Lumbar Fracture | Compression Fracture of Lumbar Spine | Burst Fracture of Thoracic Vertebra | Burst Fracture of Lumbar VertebraUnited States
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AO Clinical Investigation and Publishing DocumentationTerminatedSingle Level Stable Thoracolumbar Fracture Type AO A3 | Multiple Level Stable Thoracolumbar Fracture Type AO A3Brazil, Germany, Chile, Czechia, Italy, Portugal
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Universidade de Passo FundoCompletedBurst Thoracic Spine FracturesBrazil
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Daniel AltmanWithdrawnThoracolumbar Spine TraumaUnited States