Trial Information
Current as of January 14, 2025
Terminated
Keywords
ClinConnect Summary
This will be a prospective, randomized, partially blinded, controlled trial where patients are randomized in a centralized fashion into 2 groups: a) Control group with no intraoperative glucocorticoids administered or b) Test group with administration of 10 mg glucocorticoids intraoperatively followed with a 6-day oral methylprednisolone taper course prescribed as a Medrol Dose Pack. Each group will enroll 30 patients for a study total of 60 over approximately a one year enrollment period. Randomization will be set up using sealedenvelope.com simple randomizer. The randomization process wil...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Intra- or extra-articular distal radius fractures (AO 23-A2,3; 23B-1,2,3; 23C-1,2,3) treated with open reduction internal fixation (ORIF)
- • Age \>18
- Exclusion Criteria:
- • Open fractures
- • Pathologic fractures
- • Concomitant ipsilateral upper extremity fracture (not including distal ulna)
- • Medical contraindication to systemic glucocorticoids (insulin-dependent Diabetes mellitus, history of avascular necrosis, allergy)
- • Narcotic dependence
- • Women who are pregnant or breastfeeding
About Indiana Hand To Shoulder Center
The Indiana Hand to Shoulder Center is a leading clinical research organization dedicated to advancing the field of upper extremity care through innovative research and clinical trials. With a focus on conditions affecting the hand, wrist, elbow, and shoulder, the center combines expert clinical practice with rigorous scientific inquiry to improve treatment outcomes for patients. Committed to excellence in patient care and research integrity, the Indiana Hand to Shoulder Center collaborates with healthcare professionals and industry partners to develop and evaluate cutting-edge therapies, ultimately enhancing the quality of life for individuals with upper limb disorders.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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