Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures (NCT03898154) | Clinical Trial Compass
TerminatedPhase 4
Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures
Stopped: Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
United States38 participantsStarted 2019-07-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
QuickDASH
Timeframe: Pre-Op (day of consent) up through 12 months Post-Op
2
Visual Analog Scale Pain Score
Timeframe: Pre-Op (day of consent) up through 12 months Post-Op
3
PROMIS Pain Interference
Timeframe: Pre-Op visit (day of consent)
4
PROMIS Self-Efficacy Manage Symptoms
Timeframe: Pre-Op (day of consent)
5
PROMIS Upper Extremity (Short Form 7A)
Timeframe: Pre-Op (day of consent) up through 12 months Post-Op