Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

Sponsor

C. Liam Dwyer (Other)

Overall Status

Recruiting

CT.gov ID

NCT03898154

Collaborator

(none)

200

Enrollment

Location

Arms

40.7

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fracture	Drug: Dexamethasone Drug: Methylprednisolone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect on Wrist Range of Motion With Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures: A Randomized Controlled Trial

Actual Study Start Date :

Jul 10, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Dexamethasone Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone 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
No Intervention: Control (non-GC) group No GC administration

Arm

Intervention/Treatment

Experimental: 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

Drug: Dexamethasone

Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone

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

No Intervention: Control (non-GC) group

No GC administration

Outcome Measures

Primary Outcome Measures

QuickDASH [0-12 months]
best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand
Visual Analog Scale Pain Score [0-12 months]
best 0-10 worst; continuous scale to measure current pain level
PROMIS Pain Interference [0-12 months]
best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle
PROMIS Self-Efficacy Manage Symptoms [0-12 months]
best 0-100 worst; measures a patient's ability to cope with their symptoms related to the procedure
PROMIS Upper Extremity [0-12 months]
worst 0-100 best; measures physical function of upper extremities

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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