Actively Recruiting
Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-07
52
Participants Needed
2
Research Sites
358 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
C
Cantonal Hospital of St. Gallen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years at inclusion
- Acute traumatic burst fracture of the thoracolumbar spine (T10 to L3 vertebral body)
- Provided informed consent for study participation
You will not qualify if you...
- Injury to the posterior tension band or posterior column of the thoracolumbar spine
- Any neurological deficit (American Spinal Injury Association Impairment Scale Grade A-D)
- Pathological vertebral body fractures that may affect study participation
- Spinal fractures outside T10-L3 that may affect study participation
- Multiple trauma or Injury Severity Score greater than 16 or other injuries impairing early ambulation
- Previous spinal surgery in the thoracolumbar spine affecting participation
- Severe, progressive, or uncontrolled medical or psychiatric conditions preventing participation
- History of substance abuse affecting reliable assessment
- Pregnancy or planning to conceive during the study; negative pregnancy test required at enrollment
- Inability to follow study procedures or understand German, French, or English as judged by the investigator
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Trial Site Locations
Total: 2 locations
1
Inselspital
Bern, Switzerland, 3010
Actively Recruiting
2
Ostschweizer Wirbelsaeulenzentrum Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9007
Not Yet Recruiting
Research Team
C
Christoph E Albers, PD Dr.
CONTACT
S
Sonja Häckel, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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