Spine FA3

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Single Level Stable Thoracolumbar Fracture Type AO A3 Multiple Level Stable Thoracolumbar Fracture Type AO A3

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Surgical

Intervention Type PROCEDURE

Conservative treatment

Conservative treatment according to hospital's standard of care

Conservative treatment

Intervention Type PROCEDURE

Interventions

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Surgical

Intervention Type PROCEDURE

Conservative treatment

Intervention Type PROCEDURE

Other Intervention Names

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• Posterior open approach • Posterior minimally-invasive surgery (MIS) approach 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 Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No