Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

NCT03898154 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2018-0533
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Glucocorticoid (GC) group

EXPERIMENTAL

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; Drug: Methylprednisolone

Control (non-GC) group

NO INTERVENTION

No GC administration

Interventions

Dexamethasone DRUG

Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone

Glucocorticoid (GC) group

Methylprednisolone DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• C. Liam Dwyer: lead

Study Sites (1)

Geisinger Woodbine

Danville, Pennsylvania, 17821, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Dexamethasone; Methylprednisolone

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone

Results Point of Contact

• Title: Liam Dwyer
• Organization: Geisinger Medical Center

ldwyer@geisinger.edu

5702716700

Study Officials

• Liam Dwyer, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 1, 2019
• Study Start: July 10, 2019
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-03

Locations

US (1)