Comparing surgery and non-surgery for thoracolumbar burst fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of surgical versus non-surgical treatment for patients with acute traumatic thoracolumbar burst fractures who do not have neurological symptoms. It is a randomized controlled trial involving 52 patients who will be assigned to either receive surgery with anterior-posterior fixation or non-surgical treatment with a brace. The study aims to assess clinical outcomes, radiographic results, and complication rates over a follow-up period of at least 24 months. Data will be collected through patient files and questionnaires to ensure comprehensive evaluation.

Why it matters

Who can join: the full rules

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

Where it's running

• Inselspital
  Bern, Switzerland Recruiting
• Ostschweizer Wirbelsaeulenzentrum Kantonsspital St. Gallen
  Sankt Gallen, Switzerland Not yet recruiting

Study contacts

• Principal investigator: Christoph E Albers, PD Dr. — Inselspital Bern, Department of Orthopaedic Surgery and Traumatology
• Study coordinator: Christoph E Albers, PD Dr.
• Email: christoph.albers@insel.ch
• Phone: +41 (0) 31 664 04 40

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.