Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment

Therapuetic Areas:Orthopedics / Podiatry
Age Range:18 - 65
Start Date:October 2016
End Date:October 2022
Contact:Brigitte S. Gallo-Kopf, PhD
Phone:+41 44 200 24 06

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Thoracolumbar Burst Fractures (AOSpine A3, A4) in Neurologically Intact Patients: An Observational, Multicenter Cohort Study Comparing Surgical Versus Non-surgical Treatment

Thoracolumbar (TL) burst fractures in neurologically intact patients account for
approximately 45% of all TL spine injuries. Despite being common fractures, there is
significant variability in treatment recommendations encompassing surgery and non-surgical
treatment options. The controversy regarding optimal treatment for these injuries is fueled
by several studies which suggest a potential benefit to surgical treatment in the realm of
patient satisfaction, and the overall socio-economic burden of treatment while other studies
demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study
aims to perform a prospective cohort analysis investigating the clinical outcome of various
treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A
cost-effectiveness analysis will also be performed to identify costs and benefits of each
treatment option. More specifically a sub-group analysis will be performed for this group of
patients, which have equipoise in regards to patients treatment, as decided by a blinded
review panel.

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

- 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
We found this trial at
Morgantown, West Virginia 26506
(304) 293-0111
Phone: 304-293-3900
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Morgantown, WV
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Boston, Massachusetts 02114
Phone: 617-712-8636
Boston, MA
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
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Salt Lake City, UT
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East Syracuse, New York 13057
Phone: 315-464-8602
East Syracuse, NY
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Melbourne, 3004
Phone: +61400018838
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 267-339-3623
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
Philadelphia, PA
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San Diego, California 92103
Phone: 858-822-1288
San Diego, CA
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