Steroid Administration for Articular Fractures of the Elbow (SAFE Trial) (SAFE)
Elbow Fracture
About this trial
This is an interventional treatment trial for Elbow Fracture focused on measuring Glucocorticoid Administration
Eligibility Criteria
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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treatment Arm (Glucocorticoid)
Control Arm (Placebo)
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.
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.