ORthosis vs No Orthosis after surgically Treated traumatic thoracolumbar fractures

Recruiting

• Conditions: spine fracture; 10005944; Thoracolumbar fracture

• Registration Number: NL-OMON47142
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 45

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
- Diagnosed osteoporosis; using bisphosphonates or diagnosed by DEXA-scan
- Psychiatric history
- 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.
o Pre-existing spine deformities (scoliosis or very severe kyphosis/lordosis) which impair the use of the orthosis or aggravate pain.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter is the difference in pain after six weeks noted on the<br /><br>NRS-score.</p><br>