StUdy oN Burst Fractures (SunBurst)

Summary

Thoracolumbar (TL) burst fractures are seen in all ages and usually associated with high-energy trauma. Treatment include both surgical and non-surgical options. In cases without neurological deficit or definite rupture of the posterior ligament complex (PLC) both surgical treatment and non-surgical treatment are considered standard of care. This study aims to compare outcome between surgical and non-surgical in patients with a single level TL burst fracture (AO A3/4) in a randomized controlled trial (RCT).

Conditions

• Thoracolumbar Burst Fracture

Interventions

PROCEDURE

Surgical stabilization

The surgical stabilization can be either open or minimally invasive. The recommended procedure is posterior fixation with pedicle screws and rods. Both short and long segment fixation are allowed in the study. It is up to the treating surgeon to decide on fusion or decompression. If feasible, pedicle screws are inserted in the fractured vertebra.

Sponsors & Collaborators

• Sahlgrenska University Hospital

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• University Hospital, Umeå

  collaborator OTHER

• University Hospital, Linkoeping

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Region Örebro County

  collaborator OTHER

• Stockholm South General Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• University Hospital, Akershus

  collaborator OTHER

• Kalmar County Hospital

  collaborator OTHER

• Ryhov County Hospital

  collaborator OTHER

• Halmstad County Hospital

  collaborator OTHER

• Centrallasarettet Västerås

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Uppsala University

  lead OTHER

Principal Investigators

• Paul Gerdhem, MD, PhD · Uppsala University, Uppsala University Hospital and Karolinska Institutet

• Filip Dolatowski, MD, PhD · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

66 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2026-03-31

Completion

2036-12-31

Countries

• Norway
• Sweden

Study Locations