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 range18 Years

SexALL

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

What they're measuring

Post-operative Range of Motion of Elbow

Timeframe: Change between 2-week, 6-week, 3-month, 6-month, and final follow-up visits.

Trial details

NCT IDNCT04738318

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-10

Results submitted2023-12-12

View on ClinicalTrials.gov More Elbow Fracture trials