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Compares treatment options for Spine Fracture
Official title ORthosis vs No Orthosis After Surgically Treated Traumatic Thoracolumbar Fractures
ClinicalTrials.gov ID: NCT03097081
What this study is testing
- What it's testing
- Rationale: There is no evidence in the current literature regarding the additional value of an orthosis after surgically treated thoracolumbar spine fractures. Objective: To assess whether an orthosis provides additional pain relief compared to no orthosis after posteriorly fixated thoracolumbar spine fractures.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age 18 - 65 years
- Traumatic thoracolumbar spine fracture from thoracic 7 - lumbar 4
- AO fracture types A-C
- Undergoing surgical dorsal fixation for fracture
You likely can't join if
- 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)
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.