Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment

208 subjects (i.e., 137 per surgical group; 71 per conservative group) with TL burst
fractures AOSpine classification type A3 or A4 without neurological deficit as defined in the
inclusion/exclusion criteria, and with or without suspected Posterior Ligament Complex (PLC)
injury (M1) from T10 to L2, will be enrolled in a prospective multicenter cohort study.
Patients may have an associated B injury, but must have an A3 or A4. Patients will be
monitored prospectively for patient reported, clinical and radiologic outcomes, over a period
of 2 years post-treatment. Specifically a patient diary will measure the Oswestry Disability
Index (ODI), and employment information (indirect costs questionnaire) every second week
until 6 months post-treatment. Diary will continue every second month until 2 years
post-treatment. All interventions/examinations are considered as standard of care.

Inclusion Criteria:

- Skeletally mature, age 18 to 65 years old inclusive

- Diagnosis of AO type A3 or A4 fractures on a CT scan with or without a suspected PLC
injury (M1) from T10 to L2.

- Patients may have an associated B injury, but must have an A3 or A4.

- TLICS Score between 2-5 inclusive

- Acute fracture - diagnosis and treatment within 10 days of injury

- Ability to understand the content of the patient information / informed consent form

- Willingness and ability to participate in the clinical investigation including imaging
and FU procedures

- Investigation according to the Clinical Investigation Plan (CIP)

- Signed and dated IRB/EC-approved written informed consent

Exclusion Criteria:

- Any neurological deficit associated with the fracture. Absence of neurological deficit
will be determined with the International Standards for Neurological Classification of
Spinal Cord Injury (ISNC SCI). It will be documented the status "E" (neurologically
intact/normal) of the patient.

- Spontaneous fractures due to pathologic processes or neoplasia

- Head injuries causing inability to cooperate during hospital admission

- Open or penetrating spinal lesion (e.g. due to gun, stab, or projectile)

- Prior spinal surgeries in thoracic or lumbar spine

- Additional musculoskeletal, head or other injuries which would preclude rapid
mobilization

- Multiple trauma or Injury Severity Score (ISS) > 16

- Other co-morbidities precluding the patient to be considered as a surgical or
non-surgical candidate, i.e. burns, dementia, BMI > 40, etc.

- Any severe systemic medical disease that would exclude the patient to be a potential
candidate for surgery

- Prisoner

- Participation in any other medical device or medicinal product study within the
previous month that could influence the results of the present study

- Recent history of substance abuse (i.e., recreational drugs, alcohol) that would
preclude reliable assessment.

- Pregnancy or women planning to conceive within the study period