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No Spinal Orthosis for Lumbar Compression Fracture

N/A
Waitlist Available
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any acute, stable thoracic or lumbar compression or burst fracture appropriate for non-operative care
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of injury and at follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Awards & highlights

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.

Eligible Conditions
  • Thoracic Vertebral Fracture
  • Lumbar Compression Fracture
  • Lumbar Burst Fracture
  • Compression Fracture of Thoracic Vertebra
  • Broken Rib
  • Lumbar Fracture

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oswestry Disability Index (ODI)
Secondary outcome measures
PROMIS (Patient-Reported Outcomes Measurement Information System)- physical function
Return to Work Status
SF-12
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: No Spinal OrthosisExperimental Treatment1 Intervention
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.
Group II: Spinal Orthosis (LSO, TLSO, etc)Active Control1 Intervention
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)

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Who is running the clinical trial?

St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,645 Total Patients Enrolled
~0 spots leftby Aug 2025
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