Clinical trial NCT01751633: Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures
Official title: Comparison of Surgical Versus Conservative Treatment of AO Type A3 Thoracolumbar Fractures Without Neurological Deficits Prospective, International, Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Single Level Stable Thoracolumbar Fracture Type AO A3
Multiple Level Stable Thoracolumbar Fracture Type AO A3
Keywords: Burst fractures
Thoracic or Lumbar Vertebrae/injuries [MeSH]
Thoracic or Lumbar Vertebrae/surgery [MeSH]
Spinal Fusion/methods [MeSH]
Thoracolumbar fracture management
Quality of life
Functional outcome
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 38
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: 140 subjects patients with thoracolumbar fractures will be assigned to ei-ther conservative or surgical treatment depending on the surgeon's decision. Patients will be treated at each institution per standard of care. Surgeons will use their expertise and preferences to determine the method of surgical or conservative intervention.

Brief summary: Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3 ("burst fractures"). Although patients with burst fractures report a reduced quality of life and chronic pain, there is no clear evidence whether surgical or conservative treatment offer better functional and back-pain related outcomes. The indications for the selection of an ideal treatment for these fractures without neurological deficits remain controversial. The purpose of this study is to evaluate whether patients with thoracolumbar fractures without neurological deficit being surgically treated show faster recovery and better improvement of function than patients being conservatively treated.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Diagnosis of single or multiple stable thoracolumbar fracture(s)

  * Level T10- L3
  * Type AO A3 or A4
  * Radiologically confirmed by Rx or CT
* Fracture induced kyphotic deformity lower or equal to 20-35 degrees
* Definitive treatment (surgical or conservative) within 10 days after injury
* American Spinal Injury Association (ASIA) Impairment Scale = E (normal )
* Ability to understand patient information / informed consent form
* Willingness and ability to participate in the clinical investigation including imaging and follow-up procedures (FUs)
* Signed informed consent

Exclusion Criteria:

* Open fracture
* Polytrauma
* Pathologic fracture
* Disruption of the posterior ligamentous complex between T10 and L3
* Clinically evident osteoporosis as assessed by the investigator
* Spinal luxation
* Associated severe lesions as assessed by the investigator
* Spinal lesion due to gun or projectile
* Pre-existing spinal column deformity
* Prior spinal surgeries
* BMI \> 40 kg/m2
* Any severe medically not managed systemic disease
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reli-able assessment
* Pregnancy or women planning to conceive within the study period
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Primary outcomes:
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: 6 week follow up
Secondary outcomes:
measure: Back pain related disability (Roland-Morris Disability Questionnaire RMDQ)
timeFrame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
measure: Pain (Numeric Rating Scale (NRS))
timeFrame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU
measure: Radiologic progress taking into account RX, CT and optionally MRI
timeFrame: baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months
measure: Quality of return to work (Denis Work Scale)
timeFrame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
measure: Time to return to work
timeFrame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
measure: Conservative treatment failure rate (eg, change to surgical treatment)
timeFrame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
measure: Rates of local adverse events (AE)
timeFrame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Hospital Universitaria Cajuru
city: Porto Alegre
country: Brazil
facility: Hospital Cristo Redentor
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
city: Santiago de Chile
country: Chile
facility: Hospital Cristo Redentor
city: Liberec
country: Czechia
facility: Krajská nemocnice Liberec
city: Munich
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: Catania
country: Italy
facility: Azienda Ospedaliero - Universitaria Policlinico
city: Almada
country: Portugal
facility: Hospital Garcia e Orta, EPE
Study officials:
affiliation: Azienda Ospedaliero - Universitaria Policlinico, Catania, Italy
name: Giuseppe Barbagallo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of Parana - Curitiba, Brazil
name: Emiliano Vialle, MD
role: PRINCIPAL_INVESTIGATOR
References: