Burst Fracture, SPINAL Fracture, Spinal Instability of Thoracolumbar Region
Conditions
Keywords
Traumatic Thoracolumbar Spine Burst Fracture
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESurgical stabilization
Anterior-posterior stabilization (360°) with pedicle screws and an expandable cage
Sponsors
Insel Gruppe AG, University Hospital Bern
Cantonal Hospital of St. Gallen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation | 2 years after fracture | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in patient-related outcome measurements: EQ5D-3L | Pre-Treatment to 2 years after the fracture | Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups |
| Changes in patient-related outcome measurements: Pain visual analogue scale (VAS) | Pre-Treatment to 2 years after the fracture | Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups |
| Indirect costs | 6, 12, 26, 52, and 104 weeks | Assessed by indirect cost questionnaire and compared between treatment groups |
| Treatment data: Length of hospitalization (days) | Pre-Treatment to discharge from hospital | Inhospital data records, comparison between treatment groups |
| Treatment data: blood loss during surgery (ml) | during surgery | Inhospital data records |
| Treatment data: duration of surgery (hh: mm) | during surgery | Inhospital data records |
| Time to return to work/sports | 6, 12, 26, 52, and 104 weeks | Documented at each clinical follow-up as internal clinic standard of care, comparison between treatment groups |
| Radiological outcome: Sagittal and coronal alignment | 6, 12, 26, 52, and 104 weeks | Assessed by long-standing x-rays of the entire spine, comparison between treatment groups |
| Opioid use | Pre-Treatment, 6, 12, 26, 52, and 104 weeks | Use of oral intake of opioids, comparison between treatment groups and changes from baseline to 104 weeks |
| Radiological outcome: Mono- (A3-fractures)/Bisegmental (A4-fractures) kyphosis angle | Pre-Treatment to 2 years after the fracture | Bi-/segmental kyphosis (Gardner/Cobb angle) assessed by long-standing x-rays of the entire spine |
| Radiological outcome: Spinal fusion and fracture consolidation | 26 weeks after fracture | Spinal fusion in the surgical group and fracture consolidation in the non-surgical group assessed by CT-scan |
| Radiological outcome: Segment mobility | 52 weeks after fracture | Segment mobility assessed by functional lateral views at 52 weeks and compared between treatment groups |
| Radiological outcome: Degeneration of the intervertebral disc over time | Pre-Treatment, 52 weeks after the fracture | Degeneration of the intervertebral disc (Pfirrmann grade) |
| Radiological outcome: Progression of spinal canal stenosis | From the time of fracture, 26 weeks and 52 weeks | Assessed on CT-scan and MRI |
| Non-surgical treatment failure rate | From the time of fracture to 2 years after the fracture | 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 |
| Changes in patient-related outcome measurements: AOSpine Patient Reported Outcome Spine Trauma (PROST) | From the time of fracture to 2 years after the fracture | Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups |
| Complication rate and severity and additional surgeries | 6, 12, 26, 52, and 104 weeks | Rate and severity according to the Spine Adverse Events Severity System (SAVES) and surgical complications between treatment groups |
Countries
Switzerland
Contacts
CONTACTChristoph E Albers, PD Dr.
CONTACTSonja Häckel, Dr.
PRINCIPAL_INVESTIGATORChristoph E Albers, PD Dr.
Inselspital Bern, Department of Orthopaedic Surgery and Traumatology
STUDY_DIRECTORSonja Häckel, Dr.
Inselspital Bern, Department of Orthopaedic Surgery and Traumatology
Outcome results
None listed