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Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

Primary Purpose

Distal Radius Fracture

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Methylprednisolone
Sponsored by
C. Liam Dwyer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Geisinger WoodbineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Glucocorticoid (GC) group

Control (non-GC) group

Arm 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

No GC administration

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 28, 2019
Last Updated
December 1, 2022
Sponsor
C. Liam Dwyer
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1. Study Identification

Unique Protocol Identification Number
NCT03898154
Brief Title
Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
C. Liam Dwyer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glucocorticoid (GC) group
Arm Type
Experimental
Arm 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
Arm Title
Control (non-GC) group
Arm Type
No Intervention
Arm Description
No GC administration
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
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
Primary Outcome Measure Information:
Title
QuickDASH
Description
best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand
Time Frame
0-12 months
Title
Visual Analog Scale Pain Score
Description
best 0-10 worst; continuous scale to measure current pain level
Time Frame
0-12 months
Title
PROMIS Pain Interference
Description
best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle
Time Frame
0-12 months
Title
PROMIS Self-Efficacy Manage Symptoms
Description
best 0-100 worst; measures a patient's ability to cope with their symptoms related to the procedure
Time Frame
0-12 months
Title
PROMIS Upper Extremity
Description
worst 0-100 best; measures physical function of upper extremities
Time Frame
0-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liam Dwyer, MD
Phone
570-214-4806
Email
orthoresearch@geisinger.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Sams
Phone
570-214-6178
Email
kbsams@geisinger.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liam Dwyer, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Woodbine
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17821
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Sams
Phone
570-214-6178
Email
MSKIresearch@geisinger.edu

12. IPD Sharing Statement

Learn more about this trial

Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

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