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

Who is this study for? Adults with distal radius fractures
What treatments are being studied? Dexamethasone+Methylprednisolone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Geisinger Woodbine
RECRUITING
Danville
Contact Information
Primary
Liam Dwyer, MD
orthoresearch@geisinger.edu
570-214-4806
Backup
Kenneth Sams
kbsams@geisinger.edu
570-214-6178
Time Frame
Start Date: 2019-07-10
Estimated Completion Date: 2024-12
Participants
Target number of participants: 200
Treatments
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
No_intervention: Control (non-GC) group
No GC administration
Related Therapeutic Areas
Sponsors
Leads: C. Liam Dwyer

This content was sourced from clinicaltrials.gov