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Corticosteroid
Steroid Therapy for Distal Radius Fracture
Phase 1
Waitlist Available
Research Sponsored by Indiana Hand to Shoulder Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial compares outcomes, pain control, and recovery of wrist fracture patients who receive steroids in surgery to those who don't - 18 patients in each group will be tracked for 6 months.
Eligible Conditions
- Distal Radius Fracture
- Broken Bones
- Fractures
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Range of Motion
Secondary outcome measures
Visual Analogue Scale (VAS) Pain
Other outcome measures
Return to Work
Trial Design
2Treatment groups
Experimental Treatment
Group I: Test GroupExperimental Treatment2 Interventions
Test Group will receive 10mg intravenous dexamethasone at the time of incision, administered by the assigned anesthesiologist. Post-surgery, Test Group patients will be prescribed a 6-day oral methylprednisolone taper course.
Group II: Control GroupExperimental Treatment1 Intervention
Standard of care with no placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Methylprednisolone
2015
Completed Phase 4
~2280
Find a Location
Who is running the clinical trial?
Indiana Hand to Shoulder CenterLead Sponsor
8 Previous Clinical Trials
320 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a broken arm on the same side as your study treatment.You are dependent on narcotics.You have a broken bone that has come through the skin.You cannot take systemic glucocorticoids due to a medical condition such as insulin-dependent diabetes mellitus, a history of avascular necrosis, or an allergy.You have a specific type of broken wrist bone that was treated with a surgery called open reduction internal fixation (ORIF).
Research Study Groups:
This trial has the following groups:- Group 1: Test Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Test Group's product line compliant with FDA standards?
"Due to the fact that this is a Phase 1 trial, with limited data available on safety and efficacy, our team at Power has rated Test Group's safety as a one."
Answered by AI
Are there any current openings for this research project?
"Contrary to the information on clinicaltrials.gov, this trial does not presently have openings for participants and no updates were made after December 14th 2022. Although, there are still 358 other trials currently recruiting patients."
Answered by AI
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