Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

Phase 4

Recruiting

• Conditions: Distal Radius Fracture
• Interventions: Drug: Dexamethasone; Drug: Methylprednisolone

• Registration Number: NCT03898154
• Lead Sponsor: C. Liam Dwyer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-01
• Study Start: 2019-07-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucocorticoid (GC) group	Methylprednisolone	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
Glucocorticoid (GC) group	Dexamethasone	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Geisinger Woodbine; 🇺🇸 Danville, Pennsylvania, United States