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

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.

Study Overview

• Status: Terminated
• Conditions: Compression Fracture of Thoracic Vertebral Body; Thoracic Fracture; Lumbar Fracture; Compression Fracture of Lumbar Spine; Burst Fracture of Thoracic Vertebra; Burst Fracture of Lumbar Vertebra
• Intervention / Treatment: Other: Spinal Orthosis (LSO, TLSO); Other: No orthosis

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 month post-injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Time of injury and at follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
SF-12		time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
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'.	time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
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	follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2020
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 22, 2022

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Compression
• Other Study ID Numbers: 29976

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No