Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures (FA3)

Comparison of Surgical Versus Conservative Treatment of AO Type A3 Thoracolumbar Fractures Without Neurological Deficits Prospective, International, Multicenter Cohort Study

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.

Study Overview

• Status: Terminated
• Conditions: Single Level Stable Thoracolumbar Fracture Type AO A3; Multiple Level Stable Thoracolumbar Fracture Type AO A3
• Intervention / Treatment: Procedure: Surgical; Procedure: Conservative treatment

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Brazil
  • Curitiba, Brazil
    • Hospital Universitaria Cajuru
  • Porto Alegre, Brazil
    • Hospital Cristo Redentor
  • São Paulo, Brazil
    • Hospital Santa Marcelina
• Chile
  • Santiago de Chile, Chile
    • Hospital Cristo Redentor
• Czechia
  • Liberec, Czechia
    • Krajska Nemocnice Liberec
• Germany
  • Munich, Germany
    • Klinikum rechts der Isar der Technischen Universität München
• Italy
  • Catania, Italy
    • Azienda Ospedaliero - Universitaria Policlinico
• Portugal
  • Almada, Portugal
    • Hospital Garcia e Orta, EPE

Participation Criteria

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

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical treatment; Surgical treatment according to one of the following: Posterior open approach; Posterior minimally-invasive surgery (MIS) approach The choice of the approach will be left upon the surgeon's discretion	Procedure: Surgical; Other Names: • Posterior open approach; • Posterior minimally-invasive surgery (MIS) approach
Conservative treatment; Conservative treatment according to hospital's standard of care	Procedure: Conservative treatment; Other Names: Conservative treatment according to hospital's standard of care :; - Bed rest followed by immobilization with:; - Custom-moulded 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland-Morris Disability Questionnaire (RMDQ)	Improvement in functional outcome from baseline to 6 week follow up (FU) measured with the Roland-Morris Disability Questionnaire (RMDQ)	6 week follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
Back pain related disability (Roland-Morris Disability Questionnaire RMDQ)	Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Pain (Numeric Rating Scale (NRS))	Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU
Radiologic progress taking into account RX, CT and optionally MRI	baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months
Quality of return to work (Denis Work Scale)	Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Time to return to work	Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Conservative treatment failure rate (eg, change to surgical treatment)	Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
Rates of local adverse events (AE)	Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Giuseppe Barbagallo, MD, Azienda Ospedaliero - Universitaria Policlinico, Catania, Italy; Principal Investigator: Emiliano Vialle, MD, Catholic University of Parana - Curitiba, Brazil

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 14, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 18, 2012

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Functional outcome; Burst fractures; Thoracic or Lumbar Vertebrae/injuries [MeSH]; Thoracic or Lumbar Vertebrae/surgery [MeSH]; Spinal Fusion/methods [MeSH]; Thoracolumbar fracture management
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: Spine FA3