Comparing surgery and non-surgery for thoracolumbar burst fractures
Outcome of Surgical Versus Primary Non-Surgical Treatment of Traumatic Thoracolumbar Spine Burst Fracture in Patients Without Neurological Symptoms: A Randomized Controlled Clinical Trial
This study is testing whether surgery or wearing a brace is better for people with certain types of back fractures that don’t affect their nerves.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 2 sites (Bern and 1 other locations) |
| Trial ID | NCT05769114 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with acute traumatic burst fractures of the thoracolumbar spine and no neurological deficits.
Not a fit: Patients with injuries to the posterior column of the spine or those with neurological deficits will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment approach for thoracolumbar burst fractures, potentially improving patient outcomes.
How similar studies have performed: Other studies have explored surgical and non-surgical treatments for spinal fractures, but this specific comparison in a randomized controlled format is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bern and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.