Orthosis Versus No Orthosis After Dorsally Fixated Traumatic Thoracolumbar Fractures

What this Trial Is About

Researchers are assessing whether wearing an orthosis (a supportive brace) after surgery for traumatic thoracolumbar spine fractures provides additional pain relief compared to not wearing one. The study focuses on adults aged 18 to 65 years who have undergone posterior fixation surgery for fractures between thoracic vertebra 7 and lumbar vertebra 4. This randomized controlled trial aims to determine differences in pain at six weeks after surgery as the primary outcome, along with other effects like pain medication use, disability related to pain, quality of life, spine curvature over time, complications, hospital stay, return to work, and patient perceptions of benefit or disadvantage from the orthosis. Participants are randomly assigned to one of two groups: one group receives standard care and wears an orthosis for 10 to 12 weeks when in a vertical position, while the other group does not wear an orthosis after surgery. The intervention group deviates from the usual protocol by omitting the post-operative orthosis. This design follows current guidelines but tests whether the orthosis truly adds value in stabilized fractures. During the study, patients will have their pain measured using a numeric rating scale at multiple time points, including 2, 6, and 12 weeks post-operation, with additional assessments at 6 and 12 months for quality of life, back pain-related function, and spine curvature. Researchers will also monitor complications, hospital stay length, and patient feedback throughout the follow-up period. The total participation period covers up to one year, allowing long-term evaluation of outcomes and comparison between groups.

ORthosis vs No Orthosis After Surgically Treated Traumatic Thoracolumbar Fractures