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Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture

NCT05769114 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • SPINAL Fracture
  • Burst Fracture
  • Spinal Instability of Thoracolumbar Region

Interventions

PROCEDURE

Surgical stabilization

Anterior-posterior stabilization (360°) with pedicle screws and an expandable cage

Sponsors & Collaborators

  • Cantonal Hospital of St. Gallen

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Christoph E Albers, PD Dr. · Inselspital Bern, Department of Orthopaedic Surgery and Traumatology

  • Sonja Häckel, Dr. · Inselspital Bern, Department of Orthopaedic Surgery and Traumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-18
Primary Completion
2027-03-31
Completion
2030-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05769114 on ClinicalTrials.gov