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

AO Clinical Investigation and Publishing Documentation

Status: Terminated

Conditions: Multiple Level Stable Thoracolumbar Fracture Type AO A3; Single Level Stable Thoracolumbar Fracture Type AO A3

Treatments: Procedure: Surgical; Procedure: Conservative treatment

Study type: Observational

Funder types: Other

Identifiers

NCT01751633

Spine FA3

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 2 patient groups

Surgical treatment

Description:

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

Treatment:

Procedure: Surgical

Conservative treatment

Description:

Conservative treatment according to hospital's standard of care

Treatment:

Procedure: Conservative treatment