Clinical trial NCT05769114: Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture
Official title: Outcome of Surgical Versus Primary Non-Surgical Treatment of Traumatic Thoracolumbar Spine Burst Fracture in Patients Without Neurological Symptoms: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SPINAL Fracture
Burst Fracture
Spinal Instability of Thoracolumbar Region
Keywords: Traumatic Thoracolumbar Spine Burst Fracture
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Kantonsspital St. Gallen, St. Gallen, Switzerland
First posted: 2023-03-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation
timeFrame: 2 years after fracture
Secondary outcomes:
measure: Radiological outcome: Mono- (A3-fractures)/Bisegmental (A4-fractures) kyphosis angle
timeFrame: Pre-Treatment to 2 years after the fracture
measure: Radiological outcome: Spinal fusion and fracture consolidation
timeFrame: 26 weeks after fracture
measure: Radiological outcome: Segment mobility
timeFrame: 52 weeks after fracture
measure: Radiological outcome: Degeneration of the intervertebral disc over time
timeFrame: Pre-Treatment, 52 weeks after the fracture
measure: Radiological outcome: Progression of spinal canal stenosis
timeFrame: From the time of fracture, 26 weeks and 52 weeks
measure: Non-surgical treatment failure rate
timeFrame: From the time of fracture to 2 years after the fracture
measure: Complication rate and severity and additional surgeries
timeFrame: 6, 12, 26, 52, and 104 weeks
measure: Changes in patient-related outcome measurements: AOSpine Patient Reported Outcome Spine Trauma (PROST)
timeFrame: From the time of fracture to 2 years after the fracture
measure: Changes in patient-related outcome measurements: EQ5D-3L
timeFrame: Pre-Treatment to 2 years after the fracture
measure: Changes in patient-related outcome measurements: Pain visual analogue scale (VAS)
timeFrame: Pre-Treatment to 2 years after the fracture
measure: Indirect costs
timeFrame: 6, 12, 26, 52, and 104 weeks
measure: Treatment data: Length of hospitalization (days)
timeFrame: Pre-Treatment to discharge from hospital
measure: Treatment data: blood loss during surgery (ml)
timeFrame: during surgery
measure: Treatment data: duration of surgery (hh: mm)
timeFrame: during surgery
measure: Time to return to work/sports
timeFrame: 6, 12, 26, 52, and 104 weeks
measure: Radiological outcome: Sagittal and coronal alignment
timeFrame: 6, 12, 26, 52, and 104 weeks
measure: Opioid use
timeFrame: Pre-Treatment, 6, 12, 26, 52, and 104 weeks
Other outcomes:
measure: Radiological outcome: Fracture comminution
timeFrame: Pre-Treatment
measure: Radiological outcome: Classification of traumatic disc injury
timeFrame: Pre-treatment
Locations:
city: Bern
country: Switzerland
facility: Inselspital
city: Saint Gallen
country: Switzerland
facility: Ostschweizer Wirbelsaeulenzentrum Kantonsspital St. Gallen
Study officials:
affiliation: Inselspital Bern, Department of Orthopaedic Surgery and Traumatology
name: Christoph E Albers, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inselspital Bern, Department of Orthopaedic Surgery and Traumatology
name: Sonja Häckel, Dr.
role: STUDY_DIRECTOR
References:
citation: Gnanenthiran SR, Adie S, Harris IA. Nonoperative versus operative treatment for thoracolumbar burst fractures without neurologic deficit: a meta-analysis. Clin Orthop Relat Res. 2012 Feb;470(2):567-77. doi: 10.1007/s11999-011-2157-7. Epub 2011 Nov 5.
citation: Vaccaro AR, Oner C, Kepler CK, Dvorak M, Schnake K, Bellabarba C, Reinhold M, Aarabi B, Kandziora F, Chapman J, Shanmuganathan R, Fehlings M, Vialle L; AOSpine Spinal Cord Injury & Trauma Knowledge Forum. AOSpine thoracolumbar spine injury classification system: fracture description, neurological status, and key modifiers. Spine (Phila Pa 1976). 2013 Nov 1;38(23):2028-37. doi: 10.1097/BRS.0b013e3182a8a381.
citation: Oner FC, Wood KB, Smith JS, Shaffrey CI. Therapeutic decision making in thoracolumbar spine trauma. Spine (Phila Pa 1976). 2010 Oct 1;35(21 Suppl):S235-44. doi: 10.1097/BRS.0b013e3181f32734.
citation: Spiegl UJ, Fischer K, Schmidt J, Schnoor J, Delank S, Josten C, Schulte T, Heyde CE. The Conservative Treatment of Traumatic Thoracolumbar Vertebral Fractures. Dtsch Arztebl Int. 2018 Oct 19;115(42):697-704. doi: 10.3238/arztebl.2018.0697.