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Clinical trial

Effects of Peri-Operative Glucosteroid Administration on Outcomes Following Distal Radius Fracture

ID
Name
R20180096
Description
The primary goal of this study is to compare functional outcomes (range of motion \[flexion, extension, supination, pronation\], return to work, of patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. Secondary goals include comparison of pain control (number of pain pills consumed, visual analog scale (VAS) pain scores) between patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. The primary endpoint of this study will occur when 18 patients in each test-group complete the 6 month follow up visit for study.
Trial arms
Trial start
2018-11-06
Estimated PCD
2023-05-02
Trial end
2023-05-02
Status
Terminated
Phase
Early phase I
Treatment
Dexamethasone
Intraoperative 10 mg IV Dose
Arms:
Test Group
Methylprednisolone
The oral methylprednisolone taper course will begin on the day of surgery and will taper as noted below: Day 1: 24 mg orally (8 mg before breakfast; 4 mg after lunch; 4 mg after dinner; 8 mg at bedtime) Day 2: 20 mg orally (4 mg before breakfast; 4 mg after lunch; 4 mg after dinner; 8 mg at bedtime) Day 3: 16 mg orally (4 mg before breakfast; 4 mg after lunch; 4 mg after dinner; 4 mg at bedtime) Day 4: 12 mg orally (4 mg before breakfast; 4 mg after lunch; 4 mg at bedtime) Day 5: 8 mg orally (4 mg before breakfast; 4 mg at bedtime) Day 6: 4 mg orally (4 mg before breakfast)
Arms:
Test Group
Standard of Care
standard of care surgery
Arms:
Control Group
Size
30
Primary endpoint
Range of Motion
comparison of 10 days to 6 months post-operative measurements
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-01-23

1 organization

2 products

4 indications

Organization
Indiana Hand to Shoulder Center
Product
Dexamethasone
Indication
Fracture
Indication
Bone
Indication
Closed
Indication
Distal Radius Fracture
Product
Methylprednisolone