Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture

Insel Gruppe AG, University Hospital Bern52 enrolled

Overview

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: 1. evaluate the clinical outcome (Oswestry Disability Index) 2. evaluate the radiography result (restoration and maintenance of spinal alignment) 3. 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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 2 years after fracture

Secondary Outcomes

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

Time frame: 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

Time frame: 26 weeks after fracture

Radiological outcome: Segment mobility

Segment mobility assessed by functional lateral views at 52 weeks and compared between treatment groups

Time frame: 52 weeks after fracture

Radiological outcome: Degeneration of the intervertebral disc over time

Degeneration of the intervertebral disc (Pfirrmann grade)

Time frame: Pre-Treatment, 52 weeks after the fracture

Radiological outcome: Progression of spinal canal stenosis

Assessed on CT-scan and MRI

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Pre-Treatment to 2 years after the fracture

Indirect costs

Assessed by indirect cost questionnaire and compared between treatment groups

Time frame: 6, 12, 26, 52, and 104 weeks

Treatment data: Length of hospitalization (days)

Inhospital data records, comparison between treatment groups

Time frame: Pre-Treatment to discharge from hospital

Treatment data: blood loss during surgery (ml)

Inhospital data records

Time frame: during surgery

Treatment data: duration of surgery (hh: mm)

Inhospital data records

Time frame: during surgery

Time to return to work/sports

Documented at each clinical follow-up as internal clinic standard of care, comparison between treatment groups

Time frame: 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

Time frame: 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

Time frame: Pre-Treatment, 6, 12, 26, 52, and 104 weeks

Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts