Traumatic thoracolumbar spine fractures
Conditions
Interventions
One group will receive an orthosis after surgical fixation of thoracolumbar fracture, and the other group will not use an orthosis.
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - Age 18 – 65 years - Traumatic thoracolumbar spine fracture from thoracic 7 – lumbar 4 - AO fracture types A-C - Undergoing surgical dorsal fixation for fracture
Exclusion criteria
Exclusion criteria: - Inadequate knowledge of Dutch language or to fill in questionnaire - Complete or partial spinal cord injury (ASIA A to D) - (Additional) anterior surgical stabilization - Thoracolumbar fracture of other aetiology than traumatic, e.g. pathologic, infectious - Not able to walk before fracturing vertebra - Unable to come to the outpatient clinic (e.g. residing outside the Netherlands) - Injury Severity Score (ISS) ≥ 16 - Brain injury with Abbreviated Injury Score (AIS) ≥ 4 - Solitary Lumbar 5 fracture - Inability to wear an orthosis, most probable reasons: o BMI > 35 o Thoraco-abdominal wounds (through trauma or secondary from surgery) on places at which the orthosis contacts the body so aggravation of pain or chances of infection increase significantly. ORNOT-trial version 3 dd 21-09-2016 12 of 27 o Pre-existing spine deformities (scoliosis or very severe kyphosis/lordosis) which impair the use of the orthosis or aggravate pain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain scored on the NRS at 6 weeks post-operative. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain medication used Quality of life (EQ-5D) Backpain related function (ODI) Kyphosis as measured on x-ray | — |
Contacts
Public ContactArjen J. Smits
Outcome results
None listed