spine fracture Thoracolumbar fracture
Conditions
Interventions
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter is the difference in pain after six weeks noted on the NRS-score. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain a. as reported on the NRS scale on each day the brace is worn directly post-operative (average of 24 hours) and on 2, 6, 12 weeks and 6, 12 months (average of last week). b. Pain medication use at the same measuring moments. Rated on three steps; paracetamol, NSAID*s and opiods, noted as yes/no. 2. Quality of life a. EQ-5D-5L on day of discharge and at 12 weeks and 6, 12 months 3. Back pain related function a. ODI at 2, 6, 12 weeks and 6, 12 months. 4. Kyphosis (Cobb-angle) a. Measured on sagittal CT pre-operative and conventional standing lateral X-ray at discharge and 6, 12 weeks and 6, 12 months. 5. Increased risk of infections: a. Wound infection (culture proven or antibiotics given) b. Decubitus (clinically diagnosed and noted) c. Pulmonary infections (culture proven or antibiotics given) d. Urinary tract infections (urinary sample, culture proven or antibiotics given) 6. Ileus (clinically diagnosed, gastic drainage tube given and noted in chart) 7. Clinically relevant deep venous thrombosis (ultrasound proven and treated) 8. Hospital stay (days) 9. Return to work (weeks/days) 10. Consolidation on long term as seen on X-rays 11. Subjective feeling of: a. Feeling the need of an orthosis if in the same situation again? b. Satisfaction with orthosis c. Subjective feeling of additional value of the orthosis 12. Orthosis compliance | — |
Countries
The Netherlands
Outcome results
None listed