Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

Study Overview
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Brief Summary
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The purpose of this investigation is to compare functional outcome measures and range of motion for patients receiving glucocorticoid (GC) injections versus those not receiving GCs for the treatment of distal radius fractures. The investigators hypothesize that patients who receive GC will have improved ROM and functional outcome measures compared to patients who do not receive GC. In addition, this study aims to determine if there is a difference in rates of complications and postoperative pain control between the GC and non-GC groups. In order to accomplish these aims, the investigators will conduct a prospective, randomized, controlled investigation.

Official Title
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The Effect on Wrist Range of Motion With Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures: A Randomized Controlled Trial

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Methylprednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 18 years of age and older. Patients undergoing ORIF with VP fixation of an acute, isolated DRF with or without associated distal ulna fracture and with or without associated carpal tunnel release Exclusion Criteria: Worker's compensation patient Non-operatively treated fractures Open fractures Preoperative neurovascular injury Coexisting fractures or injuries Diabetes mellitus Allergy or contraindication to GCs Associated non-orthopedic injury that would prohibit the administration of GCs Patients currently incarcerated Pregnant patients

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucocorticoid (GC) group<br>Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6 | Drug: Dexamethasone<br>* Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone<br>Drug: Methylprednisolone<br>* Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6<br>|
| No Intervention: Control (non-GC) group<br>No GC administration | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QuickDASH | best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand | 0-12 months | 
| Visual Analog Scale Pain Score | best 0-10 worst; continuous scale to measure current pain level | 0-12 months | 
| PROMIS Pain Interference | best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle | 0-12 months | 
| PROMIS Self-Efficacy Manage Symptoms | best 0-100 worst; measures a patient's ability to cope with their symptoms related to the procedure | 0-12 months | 
| PROMIS Upper Extremity | worst 0-100 best; measures physical function of upper extremities | 0-12 months |