Clinical trial NCT02827214: Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment
Official title: Thoracolumbar Burst Fractures (AOSpine A3, A4) in Neurologically Intact Patients: An Observational, Multicenter Cohort Study Comparing Surgical Versus Non-surgical Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracolumbar Burst Fracture
Keywords: Thoracolumbar spine
Burst fractures
Conservative treatment
Surgical treatment
Thoracic or lumbar vertebrae
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: AO Foundation, AO Spine
First posted: 2016-07-11
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with thoracolumbar burst fractures

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 1 year
Secondary outcomes:
measure: AOSpine Patient Reported Outcome Spine Trauma (AOSpine Prost)
timeFrame: 2 years
measure: Quality of life EQ5D-3L
timeFrame: 2 years
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 2 years
measure: Spine Adverse Events Severity System (SAVES)
timeFrame: 2 years
measure: overall satisfaction with the treatment
timeFrame: 2 years
measure: Non-surgical treatment failure rate
timeFrame: 2 years
measure: Surgical treatment failure rate
timeFrame: 2 years
measure: indirect cost questionnaire
timeFrame: 2 years
measure: Validation of AO TL Classification System aided by the analysis of CT scans
timeFrame: 2 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego Medical Center
state: California
city: East Syracuse
country: United States
facility: SUNY Upstate
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Melbourne
country: Australia
facility: Alfred Health operating through the Alfred hospital
city: Québec
country: Canada
facility: Hopital l'Enfant-Jesus, CHU de Quebec
city: Vancouver
country: Canada
facility: Vancouver General Hospital
city: Assiut
country: Egypt
facility: Assiut University Hospitals
city: Kifisiá
country: Greece
facility: KAT Hospital
city: Coimbatore
country: India
facility: Ganga Hospital
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Iasi
country: Romania
facility: Clinical Hospital "Prof. N.Oblu"
city: Marbella
country: Spain
facility: Hospital Universitario Costa del Sol
city: Bern
country: Switzerland
facility: Inselspital, University of Bern
Study officials:
affiliation: Vancouver General Hospital
name: Marcel Dvorak, MD
role: PRINCIPAL_INVESTIGATOR
References: