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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AO Clinical Investigation and Documentation
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01751633
First received: December 14, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Single Level Stable Thoracolumbar Fracture Type AO A3
Multiple Level Stable Thoracolumbar Fracture Type AO A3
Procedure: Surgical
Procedure: Conservative treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Surgical Versus Conservative Treatment of AO Type A3 Thoracolumbar Fractures Without Neurological Deficits Prospective, International, Multicenter Cohort Study

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: 6 week follow up ] [ Designated as safety issue: No ]
    Improvement in functional outcome from baseline to 6 week follow up (FU) measured with the Roland-Morris Disability Questionnaire (RMDQ)


Secondary Outcome Measures:
  • Back pain related disability (Roland-Morris Disability Questionnaire RMDQ) [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up ] [ Designated as safety issue: No ]
  • Pain (Numeric Rating Scale (NRS)) [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU ] [ Designated as safety issue: No ]
  • Radiologic progress taking into account RX, CT and optionally MRI [ Time Frame: baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Quality of return to work (Denis Work Scale) [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up ] [ Designated as safety issue: No ]
  • Time to return to work [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up ] [ Designated as safety issue: No ]
  • Conservative treatment failure rate (eg, change to surgical treatment) [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up ] [ Designated as safety issue: No ]
  • Rates of local adverse events (AE) [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751633

Contacts
Contact: Victor Diaz, Dr. 0041814142507 victor.diaz@aofoundation.org

Locations
Brazil
Hospital Universitaria Cajuru Recruiting
Curitiba, Brazil
Contact: Emiliano Vialle, Dr.         
Principal Investigator: Emiliano Vialle, Dr.         
Hospital Cristo Redentor Recruiting
Porto Alegre, Brazil
Contact: Asdrubal Falavigna, Dr.         
Principal Investigator: Asrubal Falavigna, Dr.         
Hospital Santa Marcelina Not yet recruiting
São Paulo, Brazil
Contact: Osmar Moraes, Dr.         
Principal Investigator: Osmar Moraes, Dr.         
Chile
Hospital Cristo Redentor Recruiting
Santiago de Chile, Chile
Contact: José Flediermann, Dr.         
Principal Investigator: José Fleidermann, Dr.         
Czech Republic
Krajská nemocnice Liberec Recruiting
Liberec, Czech Republic
Contact: Roman Harcuba, Dr.         
Principal Investigator: Roman Harcuba, Dr.         
Germany
Klinikum rechts der Isar der Technischen Universität München Recruiting
Munich, Germany
Contact: Bernhard Meyer, Prof.         
Principal Investigator: Bernhard Meyer, Prof.         
Italy
Azienda Ospedaliero - Universitaria Policlinico Recruiting
Catania, Italy
Contact: Giuseppe Barbagallo, Prof.         
Principal Investigator: Giuseppe Barbagallo, Prof.         
Portugal
Hospital Garcia e Orta, EPE Recruiting
Almada, Portugal
Contact: Manuel Cunha é Sa, Dr.         
Principal Investigator: Manuel Cunha é Sa, Dr.         
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: Giuseppe Barbagallo, MD Azienda Ospedaliero - Universitaria Policlinico, Catania, Italy
Principal Investigator: Emiliano Vialle, MD Catholic University of Parana - Curitiba, Brazil
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01751633     History of Changes
Other Study ID Numbers: Spine FA3
Study First Received: December 14, 2012
Last Updated: July 24, 2014
Health Authority: Italy: Ethics Committee
Germany: Ethics Commission
Portugal: Ethics Committee for Clinical Research
Czech Republic: Ethics Committee
Netherlands: Independent Ethics Committee

Keywords provided by AO Clinical Investigation and Documentation:
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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 01, 2014