Effect of Bracing Versus No Bracing in Stable Thoracolumbar Compression and Burst Fractures

S

Saint Louis University (SLU)

Status

Terminated

Conditions

Compression Fracture of Lumbar Spine
Compression Fracture of Thoracic Vertebral Body
Thoracic Fracture
Burst Fracture of Thoracic Vertebra
Burst Fracture of Lumbar Vertebra
Lumbar Fracture

Treatments

Other: Spinal Orthosis (LSO, TLSO)
Other: No orthosis

Study type

Interventional

Funder types

Other

Identifiers

NCT03952182
29976

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1 participants in 2 patient groups

Spinal Orthosis (LSO, TLSO, etc)
Active Comparator group
Description:
Patient's in this arm will be given an orthosis for the treatment of their injury (TLSO for thoracic or upper lumbar injury, LSO for lumbar injury)
Treatment:
Other: Spinal Orthosis (LSO, TLSO)
No Spinal Orthosis
Experimental group
Description:
the patient's in this arm will not be given an orthotic. They will be given a bending restriction and otherwise remain activities as tolerated.
Treatment:
Other: No orthosis

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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