Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

C. Liam Dwyer

Status and phase: Enrolling; Phase 4

Conditions: Distal Radius Fracture

Treatments: Drug: Dexamethasone; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03898154

2018-0533 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Glucocorticoid (GC) group

Experimental group

Description:

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

Treatment:

Drug: Methylprednisolone

Drug: Dexamethasone

Control (non-GC) group

No Intervention group

Description:

No GC administration