Comparing the use of orthosis versus no orthosis after surgery for spine fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of using an orthosis after surgical treatment of traumatic thoracolumbar spine fractures. It is a randomized controlled intervention study that will compare pain relief outcomes between patients who wear an orthosis and those who do not, following posterior fixation surgery. The primary outcome will assess pain levels at six weeks post-operation, while secondary outcomes will include pain at various intervals, medication usage, quality of life, and potential complications. The study will involve Dutch-speaking patients aged 18 to 65 who have sustained specific types of thoracolumbar fractures.

Why it matters

Who can join: the full rules

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.

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  * Pre-existing spine deformities (scoliosis or very severe kyphosis/lordosis) which impair the use of the orthosis or aggravate pain.

Where it's running

• VU University medical center
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Study coordinator: AJ Smits, MD
• Email: aj.smits@amsterdamumc.nl

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.