← Back to Search

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

SAFE Trial 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

SAFE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between 2-week, 6-week, 3-month, 6-month, and final follow-up visits.

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

Uterine malignancy

myocardial infarction

atrial fibrillation,

syncope

100%

80%

60%

40%

20%

Study treatment Arm

Glucocorticoids and Rituximab

SAFE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,229 Total Patients Enrolled

1 Trials studying Elbow Fractures

50 Patients Enrolled for Elbow Fractures

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the traditionally accepted uses of Glucocorticoids?

"Glucocorticoids are commonly prescribed to combat synovitis and have the added bonus of treating conditions such as ophthalmia, sympathetic disorders, scalp structure abnormalities, and branch retinal vein occlusion."

Answered by AI

How many participants can join the research project?

"Affirmative. Clinicaltrials.gov states that this trial is actively searching for participants, with the initial post date of June 16th 2022 and last update on July 26th 2022. The study requires 144 patients from a single location to participate in order to be completed successfully."

Answered by AI

Are there any available slots for individuals interested in participating in this research project?

"Affirmative, according to clinicaltrials.gov this medical research is actively recruiting individuals. Originally posted on June 16th 2022, the trial has been updated recently on July 26th 2022 and currently requires 144 people at one site for enrollment."

Answered by AI

Is Glucocorticoids sanctioned by the US Food and Drug Administration?

"Clinical trials have indicated that Glucocorticoids are safe, and thus it was awarded a score of 3."

Answered by AI

Are there any other experiments that have been executed using Glucocorticoids?

"At this time, there are 174 Phase 3 Glucocorticoid trials in progress and 680 live studies researching the drug. While Duarte, California hosts a concentration of these trails, 23444 sites around the world are administering them as well."

Answered by AI

Recent research and studies

The Journal of Bone and Joint Surgery-American VolumeJournal

Standard Surgical Protocol to Treat Elbow Dislocations with Radial Head and Coronoid Fractures

Pugh, David M.W., Lisa M. Wild, Emil H. Schemitsch, Graham J.W. King, and Michael D. McKee. 2004. “Standard Surgical Protocol to Treat Elbow Dislocations with Radial Head and Coronoid Fractures”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/00004623-200406000-00002.

The Journal of Hand SurgeryJournal

Perioperative Glucocorticoid Administration Improves Elbow Motion in Terrible Triad Injuries

Desai, Mihir J., Andrew P. Matson, David S. Ruch, Fraser J. Leversedge, J. Mack Aldridge III, and Marc J. Richard. 2017. “Perioperative Glucocorticoid Administration Improves Elbow Motion in Terrible Triad Injuries”. The Journal of Hand Surgery. Elsevier BV. doi:10.1016/j.jhsa.2016.11.011.

Journal of Shoulder and Elbow SurgeryJournal

Surgical Treatment of Post-traumatic Elbow Stiffness: A Systematic Review

Kodde, Izaäk F., Jordy van Rijn, Michel P.J. van den Bekerom, and Denise Eygendaal. 2013. “Surgical Treatment of Post-traumatic Elbow Stiffness: A Systematic Review”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/j.jse.2012.11.010.

Journal of Shoulder and Elbow SurgeryJournal