ORthosis vs No Orthosis After Surgically Treated Traumatic Thoracolumbar Fractures

Launched by AMSTERDAM UMC, LOCATION VUMC · Mar 24, 2017

Keywords

ClinConnect Summary

This clinical trial is studying whether wearing a back brace, known as an orthosis, helps reduce pain more than not wearing one after surgery for certain spine fractures. Specifically, the trial is looking at patients who have had a traumatic thoracolumbar spine fracture, which is a break in the lower part of the spine. The main goal is to see if there’s a difference in pain levels at six weeks after surgery for those who wear the brace compared to those who do not. Other factors like the use of pain medication, quality of life, and potential complications will also be assessed.

To participate in this trial, individuals need to be between 18 and 65 years old and have a specific type of spine fracture that has been treated with surgery. Those who do not speak Dutch, have certain other spinal injuries, or have severe health issues may not be eligible. Participants will be randomly assigned to either wear the orthosis for 12 weeks during their recovery or not wear one at all. This means there is no extra risk involved, and the study aims to find out if the brace truly offers any benefits or if it might cause discomfort for some people.

Gender

ALL

Eligibility 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.