Clinical trial NCT03952182: Effect of Bracing Versus No Bracing in Stable Thoracolumbar Compression and Burst Fractures
Official title: Effect of Bracing Versus No Bracing in Stable Thoracolumbar Compression and Burst Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thoracic Fracture
Lumbar Fracture
Compression Fracture of Thoracic Vertebral Body
Compression Fracture of Lumbar Spine
Burst Fracture of Thoracic Vertebra
Burst Fracture of Lumbar Vertebra
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal orthoses have been used in the treatment of non-operative thoracic and lumbar fractures with much success. However, there has been increasing questioning as to wether or not the orthotics are necessary to have a good overall outcome. Being fitted for and acquiring braces are associated with great expense and increased hospital stays. The purpose of this study is to determine wether or not braces are required for good outcome post thoracic or lumbar fracture.

Detailed description: Several tens of patient's per year come to the Emergency Department with thoracolumbar spine compression and burst fractures that are not indicated for surgical fixation. Currently, these patients are treated non-operatively through brace wear which is either custom made for the patient or is off-the-shelf pending location of the fracture and surgeon preference. All braces are through the currently contracted orthotics company. As they are non stocked in house, waiting for the brace requires the patients to remain on "strict spine precautions" (flat bed rest in a Miami J collar, no pillows behind the head, and logrolls for turning) for anywhere from 24-48 hours. No only is this incredibly uncomfortable for the patient, it is also extending their hospital stay for at least one day and, sometimes, up to three as they wait for the brace and have it adjusted to fit appropriately. The patient's all have to then wait to work with physical therapy and occupational therapy and, finally, have upright spine films taken in the brace. The braces tend to be very uncomfortably and constricting for patient's and significantly inhibit their daily lives. The investigators are proposing that these fractures can be treated without needing bracewear and will have equivalent to superior outcomes than results while wearing the brace.

Eligibility criteria: Inclusion Criteria:

* Any acute, stable thoracic or lumbar compression or burst fracture appropriate for non-operative care

Exclusion Criteria:

* neurological deficit, pregnant, incarcerated, non-English speaking, previous spinal surgery, additional lower extremity injury affecting weight bearing, younger than 18 years of age

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 6 month post-injury
Secondary outcomes:
measure: Visual analog scale (VAS)
timeFrame: Time of injury and at follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: SF-12
timeFrame: time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: PROMIS (Patient-Reported Outcomes Measurement Information System)- physical function
timeFrame: time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Return to Work Status
timeFrame: follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
Study officials:
References: