Comparing the use of orthosis versus no orthosis after surgery for spine fractures
Orthosis Versus no Orthosis After Dorsally Fixated Traumatic Thoracolumbar Fractures
This study is testing whether wearing a brace after spine surgery helps people with fractures feel less pain compared to those who don’t wear one.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT03097081 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are Dutch-speaking individuals aged 18 to 65 with traumatic thoracolumbar spine fractures treated by posterior fixation.
Not a fit: Patients with complete or partial spinal cord injuries, those unable to wear an orthosis, or individuals with certain comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence on whether wearing an orthosis post-surgery improves pain management and recovery for patients with spine fractures.
How similar studies have performed: There is currently no evidence in the literature regarding the effectiveness of orthosis use after surgical treatment for these specific fractures, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion 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:
* 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.
Where this trial is running
Amsterdam, North Holland
- VU University medical center — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: AJ Smits, MD
- Email: aj.smits@amsterdamumc.nl
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.