Steroid Administration for Articular Fractures of the Elbow (SAFE Trial) (NCT04738318) | Clinical Trial Compass
TerminatedPhase 4
Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)
Stopped: Switched to observational study type.
United States3 participantsStarted 2022-06-16
Plain-language summary
The primary purpose of this study is to determine if perioperative glucocorticoid administration (IV intra-operative followed by a post-operative oral taper course) improves post-operative range of motion in a patient population that has sustained an intra-articular elbow fracture(s) (radial head, proximal ulna, distal humerus, or combined) that required operative fixation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
• All adults ≥18 years old with an isolated, intra-articular traumatic elbow fracture to be treated at Vanderbilt University Medical Center with operative intervention and a standardized post-operative rehab protocol.
* Intra-articular elbow fracture defined as:
* Distal humerus
* Proximal ulna
* Radial head fracture
* Combination fracture of two or more of the above
* Radiographs present confirming intra-articular injury
Exclusion Criteria
* Patients with bilateral elbow fractures
* Patients with an altered mental status
* Pregnant
* Allergy or contra-indication to glucocorticoid administration
* Type 1 or Type 2 diabetes
* Pre-injury limitation in elbow range or motion (patient reported)
* Unable to provide consent for themselves
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-operative Range of Motion of Elbow
Timeframe: Change between 2-week, 6-week, 3-month, 6-month, and final follow-up visits.