Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

NCT ID: NCT03898154

Last Updated: 2024-05-01

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-10

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone

Methylprednisolone

Intervention Type DRUG

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexamethasone

Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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C. Liam Dwyer

OTHER

Sponsor Role lead

Responsible Party

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C. Liam Dwyer

Staff Physician

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Liam Dwyer, MD

Role: CONTACT

570-214-4806

Kenneth Sams

Role: CONTACT

570-214-6178

Facility Contacts

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Kenneth Sams

Role: primary

570-214-6178

Other Identifiers

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2018-0533

Identifier Type: -

Identifier Source: org_study_id

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