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

Primary Purpose

Thoracic Fracture, Lumbar Fracture, Compression Fracture of Thoracic Vertebral Body

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Orthosis (LSO, TLSO)
No orthosis
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Saint Louis University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Spinal Orthosis (LSO, TLSO, etc)

No Spinal Orthosis

Arm 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)

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.

Outcomes

Primary Outcome Measures

Oswestry Disability Index (ODI)
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

Visual analog scale (VAS)
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
SF-12
PROMIS (Patient-Reported Outcomes Measurement Information System)- physical function
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'.
Return to Work Status
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

Full Information

First Posted
May 13, 2019
Last Updated
March 22, 2022
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT03952182
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment and follow up concerns during Covid-19 pandemic
Study Start Date
January 5, 2020 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Orthosis (LSO, TLSO, etc)
Arm Type
Active Comparator
Arm 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)
Arm Title
No Spinal Orthosis
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Spinal Orthosis (LSO, TLSO)
Intervention Description
spinal orthosis prescribed for specific spinal fracture (TLSO for thoracic or high lumbar fracture, LSO for lumbar fracture)
Intervention Type
Other
Intervention Name(s)
No orthosis
Intervention Description
no orthotic given for spinal fracture. These patient's will be given a bending restriction
Primary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
6 month post-injury
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
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
Time Frame
Time of injury and at follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Title
SF-12
Time Frame
time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Title
PROMIS (Patient-Reported Outcomes Measurement Information System)- physical function
Description
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'.
Time Frame
time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Title
Return to Work Status
Description
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
Time Frame
follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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

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