Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03898154
• Other study ID #: 2018-0533
• Status: Recruiting
• Phase: Phase 4
• Start date: July 10, 2019
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: Geisinger Clinic
• Contact: Liam Dwyer, MD
• Phone: 570-214-4806
• Email: orthoresearch[@]geisinger.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Drug:
• Dexamethasone
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone
• 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

Locations

Country	Name	City	State
United States	Geisinger Woodbine	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
C. Liam Dwyer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QuickDASH	best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand	0-12 months
Primary	Visual Analog Scale Pain Score	best 0-10 worst; continuous scale to measure current pain level	0-12 months
Primary	PROMIS Pain Interference	best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle	0-12 months
Primary	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
Primary	PROMIS Upper Extremity	worst 0-100 best; measures physical function of upper extremities	0-12 months