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

NCT03952182 | Terminated DMC

• 1 other identifier: 29976
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Visual analog scale (VAS)

  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

  time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Return to Work Status

  follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

Study Arms (2)

Spinal Orthosis (LSO, TLSO, etc)

ACTIVE COMPARATOR

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)

No Spinal Orthosis

EXPERIMENTAL

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

Interventions

Spinal Orthosis (LSO, TLSO) OTHER

spinal orthosis prescribed for specific spinal fracture (TLSO for thoracic or high lumbar fracture, LSO for lumbar fracture)

Spinal Orthosis (LSO, TLSO, etc)

No orthosis OTHER

no orthotic given for spinal fracture. These patient's will be given a bending restriction

No Spinal Orthosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 16, 2019
• Study Start: January 5, 2020
• Primary Completion: March 15, 2020
• Study Completion: March 22, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

US (1)