Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

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

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.

Study Overview

• Status: Terminated
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Drug: Dexamethasone; Drug: Methylprednisolone

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17821
      • Geisinger Woodbine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucocorticoid (GC) group; 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; Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone; Drug: Methylprednisolone; 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
No Intervention: Control (non-GC) group; No GC administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QuickDASH	QuickDash scale is designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper extremity (arm, shoulder, and hand). Scale is 0-100, with 0 being no disability (best outcome) and 100 being full disability (worst outcome).	Pre-Op (day of consent) up through 12 months Post-Op
Visual Analog Scale Pain Score	Visual Analog Scale Pain Score is a subjective pain scale reported by patients to assess current pain levels for their condition being seen in clinic. Scale is 0-10, with 0 being no pain at all (best outcome), 10 being worst pain imaginable (worst outcome).	Pre-Op (day of consent) up through 12 months Post-Op
PROMIS Pain Interference	PROMIS Pain Interference scale measuring how pain impacts daily activities, social life, and emotional well-being. Scale is 40.7- 77 with 40.7 being the no impact on activity (best outcome), and 77 being worst impact on daily activity (worst outcome).	Pre-Op visit (day of consent)
PROMIS Self-Efficacy Manage Symptoms	PROMIS Self-Efficacy Manage Symptoms is a scale that measures a person's confidence in managing symptoms, such as pain or fatigue, and preventing them from interfering with daily life. Scale is 22.67-63.85 with 22.67 meaning no confidence in managing symptoms (worst outcome) and 63.85 being full confidence in managing symptoms (best outcome).	Pre-Op (day of consent)
PROMIS Upper Extremity (Short Form 7A)	PROMIS Upper Extremity Scale measures the self-reported functioning of the arms, shoulders, hands, and fingers. Scale is 16.3-58.2, with 16.3 being severe functional impact (worst outcome) and 58.2 being no functional issues (best outcome).	Pre-Op (day of consent) up through 12 months Post-Op

Collaborators and Investigators

• Sponsor: C. Liam Dwyer
• Investigators: Principal Investigator: Liam Dwyer, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Wrist Injuries; Wrist Fractures; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Prednisolone; Dexamethasone; Methylprednisolone
• Other Study ID Numbers: 2018-0533 (M D Anderson Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes