Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures
NCT ID: NCT03898154
Last Updated: 2024-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2019-07-10
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Control (non-GC) group
No GC administration
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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C. Liam Dwyer
OTHER
Responsible Party
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C. Liam Dwyer
Staff Physician
Principal Investigators
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Liam Dwyer, MD
Role: PRINCIPAL_INVESTIGATOR
Geisinger Clinic
Locations
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Geisinger Woodbine
Danville, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-0533
Identifier Type: -
Identifier Source: org_study_id
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