StUdy oN Burst Fractures (SunBurst)

Uppsala University

Status: Active, not recruiting

Conditions: Thoracolumbar Burst Fracture

Treatments: Procedure: Surgical stabilization

Study type: Interventional

Funder types: Other

Identifiers

NCT05003180

SB-PG-PF-OW-SM-2021-SunBurst

2020-00493

Details and patient eligibility

About

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).

Full description

The study is an international, multicenter, randomized controlled trial. 202 patients with a single level TL burst fracture will be enrolled in the study. They will be randomized 1:1 to either surgery with posterior fixation or non-surgical treatment. The study is pragmatical in its approach, i.e., the treating physician can decide on details of the surgical treatment as well as details of the non-surgical treatment. In non-surgically treated patients brace treatment is not required, but a hyperextension brace may be offered. The subjects will be followed with patient reported outcomes, clinical assessments, and radiological assessments. Data will be collected from questionnaires, patient files or national registers to compare sick leave, medical complications, pharmaceutical prescriptions and overall costs for each treatment.

Enrollment: 202 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A single level thoracolumbar (Th10-L3) burst fracture, A3 or A4, according to the AO Spine classification
• Aged 18-66 years
• Informed consent
• Acute injury with diagnosis and treatment within 2 weeks
• May have minor fractures in adjacent vertebras if these fractures in themselves would not have resulted in any treatment
• May have a single nerve root injury

Exclusion criteria

• Unable to consent, no consent given or not informed
• Neurological injury involving more than a single level root, i.e., spinal cord and/or cauda equina injury
• Definite rupture of the posterior tension band (through bony and/or ligamentous structures) verified on MRI
• Patients with ankylosing spinal disorders spanning the fracture area
• Prior spinal surgeries within the fractured area
• Open vertebral fracture
• Additional injury which would impair early ambulation, e.g., long bone fractures, severe head injury, long-lasting intensive care
• Patients not deemed suitable due to severe co-morbidities. (E.g., established osteoporosis that would impair the possibility to maintain integrity of spinal implants, pathological fractures, severe cardiac or pulmonary compromise, or other systemic disease that would result in such high anesthesiologic risk that surgery would not be attempted.)
• Patients already included in the study cannot be randomized again if they get an additional spine fracture

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

Surgical

Active Comparator group

Description:

Surgical stabilization. Brace treatment will not be used postoperative. Early ambulation after surgery is encouraged. Surgery is to be performed within 2 weeks from the injury. The choice of supplier and brand of implants are based on the preference of each participating center. Physiotherapy and other measures of rehabilitation are prescribed on an individual basis.

Treatment:

Procedure: Surgical stabilization

Non-surgical treatment

No Intervention group

Description:

No surgical stabilization is performed. Early ambulation after treatment randomization is encouraged. Brace treatment is not required, but a standard three-point hyperextension brace may be offered up to 3 months for pain relief. The choice of supplier and brand of brace are based on the preference of each participating center. The brace will only be used upon mobilization. Brace use will be estimated by the patient at the 3-4 months follow-up. Physiotherapy and other measures of rehabilitation are prescribed on an individual basis.