Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment

AO Innovation Translation Center

Status: Completed

Conditions: Thoracolumbar Burst Fracture

Study type: Observational

Funder types: Other

Identifiers

NCT02827214

Spine_TL-A3-A4

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 213 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

213 participants in 2 patient groups

Surgical treatment

Description:

Several surgical treatments exist to treat the fractures included in the study. The following section describes the different surgical treatment modalities in more detail Approaches: * Open short segment surgical fixation (1 level above and below the fracture level) with or without posterior decompression * Open long segment posterior fixation (2 or more levels above, 2 or more levels below) with or without posterior decompression * Posterior short or long fixation with posterolateral corpectomy and reconstruction * Anterior alone instrumentation * Combined Anterior Posterior (AP) instrumentation * Percutaneous posterior fixation combined with anterior instrumentation * Percutaneous posterior fixation with or without vertebroplasty

Non-surgical treatment

Description:

Non-surgical treatment is defined as bed rest followed by immobilization with: * Custom-molded 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)