Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Dexamethasone; Glucocorticoids; Methylprednisolone

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

• Open fracture

• Traumatic brain injury

• Other concomitant orthopaedic injury to the ipsilateral extremity

• Other trauma requiring hospital admission

• Pregnant

• Pre-operative steroid use

• Allergy or contra-indication to glucocorticoid administration

• Type 1 or Type 2 diabetes

• Inflammatory arthritis

• Pre-injury limitation in elbow range or motion (patient reported)

• Unable to provide consent for themselves