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

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Liam Dwyer, MD; Phone Number: 570-214-4806; Email: orthoresearch@geisinger.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• Masking: NONE

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	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

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 (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

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): December 2, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 2018-0533 (Other Identifier: 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