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

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ClinicalTrials.gov Identifier: NCT03952182
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
William Behrens, MD, St. Louis University

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.

Condition or disease Intervention/treatment Phase
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 Other: Spinal Orthosis (LSO, TLSO) Other: No orthosis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Bracing Versus No Bracing in Stable Thoracolumbar Compression and Burst Fractures
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: Spinal Orthosis (LSO, TLSO, etc)
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)
Other: Spinal Orthosis (LSO, TLSO)
spinal orthosis prescribed for specific spinal fracture (TLSO for thoracic or high lumbar fracture, LSO for lumbar fracture)

Experimental: No Spinal Orthosis
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.
Other: No orthosis
no orthotic given for spinal fracture. These patient's will be given a bending restriction




Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 6 month post-injury ]
    Primary outcome is the ODI which is a a self-completed questionnaire over ten topics regarding pain, lifting, ability to perform activities of daily living, ability to walk, sit, stand, one's sexual function, social life, sleep quality, and ability to travel. Each category has six different statements from which the patient can choose to best describe their current status. Each question is then scored on a scale from 0-5. Scores are summed and then doubled. The index is from 0-100 with zero being no disability and one hundred being maximally disabled.


Secondary Outcome Measures :
  1. Visual analog scale (VAS) [ Time Frame: Time of injury and at follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
    VAS is a continuous scale represented as a horizontal line with vertical dashes numbered 0-10. Each number is given a pain intensity descriptor that ranges from "no pain" (score of 1) to "worst imaginable pain" (score of 10). The patient is asked to rate the pain they are currently experiencing on that scale from 1-10

  2. SF-12 [ Time Frame: time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
  3. PROMIS (Patient-Reported Outcomes Measurement Information System)- physical function [ Time Frame: time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
    PROMIS is a U.S. NIH initiative that is an item bank of self-administered questions to measure physical function. This includes functionality of one's upper extremities (dexterity), lower extremities (mobility), neck, back, as well as ability to perform activities of daily living. This assessment measures current function rather than function over a time period. Each question has five response options ranging in value from 1-5. The total raw score for the form is the sum of the values of the response to each question. The raw score (which can range from 10 (worst) to 50 (best) is then compared to a PROMIS specific conversion chart to the appropriate T-score. A T-score of roughly 50 is considered 'average' and 'slightly sicker than the general population'.

  4. Return to Work Status [ Time Frame: follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
    Patient's will be asked if they currently work at time of injury and at each consecutive follow up appointment will be asked if they have returned to work



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952182


Locations
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United States, Missouri
Saint Louis University Hospital Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Sarah Dawson, MD    314-577-8527    sarah.dawson@health.slu.edu   
Contact: William Behrens       will.behrens@health.slu.edu   
Sponsors and Collaborators
St. Louis University

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Responsible Party: William Behrens, MD, Resident Physician, St. Louis University
ClinicalTrials.gov Identifier: NCT03952182     History of Changes
Other Study ID Numbers: 29976
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Compression
Wounds and Injuries