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ORthosis vs No Orthosis After Surgically Treated Traumatic Thoracolumbar Fractures

RecruitingNAAges 18 Years - 65 YearsAllAmsterdam UMC, location VUmc
NCT03097081 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale: There is no evidence in the current literature regarding the additional value of an orthosis after surgically treated thoracolumbar spine fractures. Objective: To assess whether an orthosis provides additional pain relief compared to no orthosis after posteriorly fixated thoracolumbar spine fractures. Primary outcome is difference in pain at six weeks post-operatively. Secondary objectives are pain at other moments, pain medication used, pain related disability, quality of life, long-term kyphosis, possible complications, hospital stay, return to work and subjective feeling on benefit or disadvantage from the orthosis. Study design: Randomized controlled intervention study, non-inferiority trial. Study population: Dutch speaking patients presented at the VU university medical centre, 18 - 65 years old with a traumatic thoracolumbar spine fracture from Th7 - L4 surgically tr

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📋 Eligibility rules (as published)
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: * 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: * BMI \> 35 * 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. 12 of 27 * Pre-existing spine deformities (scoliosis or very severe kyphosis/lordosis) which impair the use of the orthosis or aggravate pain.
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What it tests

  • No orthosis
  • Orthosis
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Where

1 site
VU University medical center
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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