Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture

ConditionsSPINAL Fracture Burst Fracture Spinal Instability of Thoracolumbar Region

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Surgical stabilization
Procedure/Surgery
Anterior-posterior stabilization (360°) with pedicle screws and an expandable cage

Treatment groups

52 Participants

are divided into 3 treatment groups

Group A: Surgical treatmentActive comparator 1 intervention

Group B: Non-surgical treatmentNo intervention 0 interventions

Group C: Observational armOther 1 intervention

Trial outcomes

Primary outcomes

The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation

ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life.

Time frame

2 years after fracture

Secondary outcomes

Radiological outcome: Mono- (A3-fractures)/Bisegmental (A4-fractures) kyphosis angle

Bi-/segmental kyphosis (Gardner/Cobb angle) assessed by long-standing x-rays of the entire spine

Time frame

Pre-Treatment to 2 years after the fracture

Radiological outcome: Spinal fusion and fracture consolidation

Spinal fusion in the surgical group and fracture consolidation in the non-surgical group assessed by CT-scan

Time frame

26 weeks after fracture

Radiological outcome: Segment mobility

Segment mobility assessed by functional lateral views at 52 weeks and compared between treatment groups

Time frame

52 weeks after fracture

Radiological outcome: Degeneration of the intervertebral disc over time

Degeneration of the intervertebral disc (Pfirrmann grade)

Time frame

Pre-Treatment, 52 weeks after the fracture

Other outcomes

Radiological outcome: Fracture comminution

Fracture comminution of the vertebral body

Time frame

Pre-Treatment

Radiological outcome: Classification of traumatic disc injury

Sanders Classification

Time frame

Pre-treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Cantonal Hospital of St. Gallen

Collaborator

Source ClinicalTrials.gov

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