Status:
TERMINATED
Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Elbow Fracture
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 mo...
Detailed Description
Elbow fractures are complex injuries that often involve the articular surface, are in close proximity to critical neurovascular structures, and are prone to post-operative complications. Complications...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04738318
Start Date
June 16 2022
End Date
March 10 2023
Last Update
December 29 2023
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232