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Corticosteroid

Glucocorticoids for Elbow Fractures (SAFE Trial)

Phase 4
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between 2-week, 6-week, 3-month, 6-month, and final follow-up visits.
Awards & highlights

Summary

This trial will test whether giving steroids during and after surgery can improve range of motion for people with elbow fractures that needed surgery.

Eligible Conditions
  • Elbow Fractures

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between 2-week, 6-week, 3-month, 6-month, and final follow-up visits.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between 2-week, 6-week, 3-month, 6-month, and final follow-up visits. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-operative Range of Motion of Elbow

Side effects data

From 2017 Phase 4 trial • 20 Patients • NCT02169219
25%
Severe flares
10%
Thyroid maligancy
5%
Uterine malignancy
5%
myocardial infarction
5%
atrial fibrillation,
5%
syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Glucocorticoids and Rituximab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm (Glucocorticoid)Experimental Treatment1 Intervention
Patients will receive a single intraoperative dose of 10mg of intravenous dexamethasone. Following surgery, the participant will be provided with a 1) six-day oral methylprednisolone taper course.
Group II: Control Arm (Placebo)Placebo Group1 Intervention
Patients will receive a single intraoperative dose of 10 mg of saline. Following surgery, the participant will be provided with a six-day placebo course.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glucocorticoids
2011
Completed Phase 4
~1250

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
869 Previous Clinical Trials
678,621 Total Patients Enrolled
1 Trials studying Elbow Fractures
50 Patients Enrolled for Elbow Fractures
~1 spots leftby Jul 2025
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