Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture

Study Overview
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Brief Summary
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Treatment for acute traumatic thoracolumbar burst fractures differs significantly across the world in patients without neurological impairments and without damage to the posterior column of the spine. This randomized controlled, non-inferiority clinical trial's goal is to evaluate the effectiveness of surgery versus initial non-surgical treatment for patients with traumatic thoracolumbar spine burst fractures who don't have any neurological symptoms. The study's precise objectives are to: evaluate the clinical outcome (Oswestry Disability Index) evaluate the radiography result (restoration and maintenance of spinal alignment) determine the prevalence of complications at least 24 months of follow-up of neurologically unaffected patients with acute traumatic burst fractures. Both groups will get the same therapy using standardized methods: The surgical group's entire patient population will get combined anterior-posterior (360°) spinal fusion therapy. Three-point hyperextension orthoses will be used to treat all patients in the non-surgical group for six weeks following the injury.

Detailed Description
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The research is a single-center, nationwide, randomized controlled trial. Over a two-year period, 52 patients with a thoracolumbar burst fracture will enroll in the study. They will be assigned randomly (1:1) to either non-surgical treatment with a brace or surgery with anterior-posterior fixation. A prospective data collection will be asked of subjects who decline randomization (observational arm). The subjects will be evaluated clinically, radiologically, and based on patient-reported outcomes over the course of two years. Both patient files and questionnaires will be used to collect data.

Official Title
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Outcome of Surgical Versus Primary Non-Surgical Treatment of Traumatic Thoracolumbar Spine Burst Fracture in Patients Without Neurological Symptoms: A Randomized Controlled Clinical Trial

Conditions
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SPINAL Fracture, Burst Fracture, Spinal Instability of Thoracolumbar Region

Intervention / Treatment
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* Procedure: Surgical stabilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 70 years at inclusion Acute traumatic burst fracture of the thoracolumbar spine (10th thoracic to 3rd lumbar vertebral body) Informed consent for study participation Exclusion Criteria: Injury of the posterior tension band/posterior column of the thoracolumbar spine Any neurological deficit (American Spinal Injury Association Impairment Scale [AISA] Grade A-D) Pathological vertebral body fractures (diagnosed by MRI and CT scan), which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study Concomitant spinal fractures at any other level of the spine outside the T10-L3 level, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study Multiple trauma or Injury Severity Score (ISS) > 16 or additional injuries according to the investigator may, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study (impairment of early ambulation) Any known previous spinal surgery in the thoracolumbar spine, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study Any severe, progressive, or uncontrolled medical or psychiatric condition, or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study Known history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment in the opinion of the investigator Pregnancy or women planning to conceive within the study period. All women included in this study must have a negative blood pregnancy test (human chorionic gonadotrophin (hCG) blood level at visit 1. If pregnancy occurs during the study period, the patients drop out of the study Inability to follow the procedures of the study, e.g., due to inability to understand German, French or English, which, according to the investigator, may jeopardize the patient in case of participation in the study or prevents the patient from participating in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical treatment<br>The surgeon will perform a minimally invasive (percutaneous) posterior stabilization of the injured spinal segments. Transpedicular screws will be inserted into the vertebral body superior and inferior to the fractured vertebra under fluoroscopic control. In a second stage procedure a lumbo- or thoracotomy (depending on the fracture level below or above the diaphragm) is performed to remove the fractured part of the vertebral body (hemicorporectomy) including the intervertebral disc segments. The resulting void is replaced by an (expandable) spacer/cage. | Procedure: Surgical stabilization<br>* Anterior-posterior stabilization (360°) with pedicle screws and an expandable cage<br>* Other names: 360°-Stabilization;|
| No Intervention: Non-surgical treatment<br>The patients will receive an external bracing (3-point hyperextension brace) for six weeks, which must be always worn except when lying flat in bed. The brace is adjusted by an experienced orthopedist. A physiotherapist will instruct the patient to accomplish daily activities with the restriction he or she will have by wearing the brace. | |
| Other: Observational arm<br>Patients who do not agree to randomization will be given the option to participate in the observational arm of the study. Their treatment will be surgical fixation with an anterior-posterior stabilization (as per our current internal hospital standard). | Procedure: Surgical stabilization<br>* Anterior-posterior stabilization (360°) with pedicle screws and an expandable cage<br>* Other names: 360°-Stabilization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation | ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life. | 2 years after fracture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological outcome: Mono- (A3-fractures)/Bisegmental (A4-fractures) kyphosis angle | Bi-/segmental kyphosis (Gardner/Cobb angle) assessed by long-standing x-rays of the entire spine | Pre-Treatment to 2 years after the fracture | 
| Radiological outcome: Spinal fusion and fracture consolidation | Spinal fusion in the surgical group and fracture consolidation in the non-surgical group assessed by CT-scan | 26 weeks after fracture | 
| Radiological outcome: Segment mobility | Segment mobility assessed by functional lateral views at 52 weeks and compared between treatment groups | 52 weeks after fracture | 
| Radiological outcome: Degeneration of the intervertebral disc over time | Degeneration of the intervertebral disc (Pfirrmann grade) | Pre-Treatment, 52 weeks after the fracture | 
| Radiological outcome: Progression of spinal canal stenosis | Assessed on CT-scan and MRI | From the time of fracture, 26 weeks and 52 weeks | 
| Non-surgical treatment failure rate | Proportion/frequency of patients in the non-surgery group that received surgery later, if there is a clinical indication (spinal instability measured by a kyphosis > 30 degrees on x-ray, intolerable pain, delayed onset of neurological symptoms) or if the patient is not satisfied after treatment | From the time of fracture to 2 years after the fracture | 
| Complication rate and severity and additional surgeries | Rate and severity according to the Spine Adverse Events Severity System (SAVES) and surgical complications between treatment groups | 6, 12, 26, 52, and 104 weeks | 
| Changes in patient-related outcome measurements: AOSpine Patient Reported Outcome Spine Trauma (PROST) | Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups | From the time of fracture to 2 years after the fracture | 
| Changes in patient-related outcome measurements: EQ5D-3L | Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups | Pre-Treatment to 2 years after the fracture | 
| Changes in patient-related outcome measurements: Pain visual analogue scale (VAS) | Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups | Pre-Treatment to 2 years after the fracture | 
| Indirect costs | Assessed by indirect cost questionnaire and compared between treatment groups | 6, 12, 26, 52, and 104 weeks | 
| Treatment data: Length of hospitalization (days) | Inhospital data records, comparison between treatment groups | Pre-Treatment to discharge from hospital | 
| Treatment data: blood loss during surgery (ml) | Inhospital data records | during surgery | 
| Treatment data: duration of surgery (hh: mm) | Inhospital data records | during surgery | 
| Time to return to work/sports | Documented at each clinical follow-up as internal clinic standard of care, comparison between treatment groups | 6, 12, 26, 52, and 104 weeks | 
| Radiological outcome: Sagittal and coronal alignment | Assessed by long-standing x-rays of the entire spine, comparison between treatment groups | 6, 12, 26, 52, and 104 weeks | 
| Opioid use | Use of oral intake of opioids, comparison between treatment groups and changes from baseline to 104 weeks | Pre-Treatment, 6, 12, 26, 52, and 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Thoracolumbar Spine Burst Fracture