NCT05769114 Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture
| NCT ID | NCT05769114 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | SPINAL Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2023-04-18 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2023-04-18 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Christoph E Albers, PD Dr.
PRINCIPAL INVESTIGATOR
Inselspital Bern, Department of Orthopaedic Surgery and Traumatology
Frequently Asked Questions
Who can join the NCT05769114 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying SPINAL Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05769114 currently recruiting?
Yes, NCT05769114 is actively recruiting participants. Contact the research team at christoph.albers@insel.ch for enrollment information.
Where is the NCT05769114 trial being conducted?
This trial is being conducted at Bern, Switzerland, Sankt Gallen, Switzerland.
Who is sponsoring the NCT05769114 clinical trial?
NCT05769114 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Christoph E Albers, PD Dr. at Inselspital Bern, Department of Orthopaedic Surgery and Traumatology. The trial plans to enroll 52 participants.