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

NCT01751633 | Terminated

• 1 other identifier: Spine FA3
• Study Type: observational
• Target: 38
• Locations: 6 countries
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

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

Conservative treatment

Conservative treatment according to hospital's standard of care

Procedure: Conservative treatment

Interventions

Surgical PROCEDURE

Also known as: • Posterior open approach, • Posterior minimally-invasive surgery (MIS) approach

Surgical treatment

Conservative treatment PROCEDURE

Also known as: 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)

Conservative treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (8)

Hospital Universitaria Cajuru

Curitiba, Brazil

Location

Hospital Cristo Redentor

Porto Alegre, Brazil

Location

Hospital Santa Marcelina

São Paulo, Brazil

Location

Hospital Cristo Redentor

Santiago, Chile

Location

Krajská nemocnice Liberec

Liberec, Czechia

Location

Klinikum rechts der Isar der Technischen Universität München

Munich, Germany

Location

Azienda Ospedaliero - Universitaria Policlinico

Catania, Italy

Location

Hospital Garcia e Orta, EPE

Almada, Portugal

Location

MeSH Terms

Interventions

Surgical Procedures, Operative; Conservative Treatment; Calcium Sulfate

Intervention Hierarchy (Ancestors)

Therapeutics; Calcium Compounds; Inorganic Chemicals; Minerals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Giuseppe Barbagallo, MD

  Azienda Ospedaliero - Universitaria Policlinico, Catania, Italy

  PRINCIPAL INVESTIGATOR

• Emiliano Vialle, MD

  Catholic University of Parana - Curitiba, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 18, 2012
• Study Start: January 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

CL (1); DE (1); BR (3); CZ (1); IT (1); PT (1)