Distal Radius Steroid

Study Overview
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Brief Summary
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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.

Detailed Description
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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 will ensure balance between both arms based on sex and age of patients enrolled. All patients scheduled for distal radius ORIF will be screened to meet inclusion/exclusion criteria. Patients will be randomized preoperatively by the research coordinator, based on a 1:1 weighting, upon obtaining to consent to either Control or Test group. Post-op therapists will be blinded to the patient treatment group until completion of protocol activities for each patient. After surgery, patients will be followed for a duration of at least 6 months. Interval follow-up information will be collected at 10 days, 6 weeks, 3 months, and 6 months. 3-view wrist radiographs will be taken at each follow-up visit.

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

Conditions
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Fractures, Bone, Fractures, Closed, Radius Fracture Distal

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Methylprednisolone
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>Test Group will receive 10mg intravenous dexamethasone at the time of incision, administered by the assigned anesthesiologist. Post-surgery, Test Group patients will be prescribed a 6-day oral methylprednisolone taper course. | Drug: Dexamethasone<br>* Intraoperative 10 mg IV Dose<br>Drug: Methylprednisolone<br>* 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)<br>|
| Other: Control Group<br>Standard of care with no placebo | Other: Standard of Care<br>* standard of care surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Active and Passive degrees of flexion, extension in the wrist. Forearm degrees of supination and pronation | comparison of 10 days to 6 months post-operative measurements | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) Pain | patient rates pain on a visual scale from no pain to worst possible pain | 6 Months |