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

Terminated

• Conditions: Multiple Level Stable Thoracolumbar Fracture Type AO A3; Single Level Stable Thoracolumbar Fracture Type AO A3
• Interventions: Procedure: Conservative treatment; Procedure: Surgical

• Registration Number: NCT01751633
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-18
• Study Start: 2013-01
• Primary Completion: 2015-03
• Study Completion: 2015-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Conservative treatment	Conservative treatment according to hospital's standard of care
Surgical treatment	Surgical	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of return to work (Denis Work Scale)	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
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
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
Back pain related disability (Roland-Morris Disability Questionnaire RMDQ)	Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up

Trial Locations

Locations (7)

Hospital Universitaria Cajuru; 🇧🇷 Curitiba, Brazil

Hospital Santa Marcelina; 🇧🇷 São Paulo, Brazil

Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munich, Germany

Krajská nemocnice Liberec; 🇨🇿 Liberec, Czechia

Hospital Garcia e Orta, EPE; 🇵🇹 Almada, Portugal

Azienda Ospedaliero - Universitaria Policlinico; 🇮🇹 Catania, Italy

Hospital Cristo Redentor; 🇨🇱 Santiago de Chile, Chile