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Distal Radius Steroid

Primary Purpose

Fractures, Bone, Fractures, Closed, Radius Fracture Distal

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Methylprednisolone
Standard of Care
Sponsored by
Indiana Hand to Shoulder Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures, Bone

Eligibility Criteria

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

Inclusion Criteria: Intra- or extra-articular distal radius fractures (AO 23-A2,3; 23B-1,2,3; 23C-1,2,3) treated with open reduction internal fixation (ORIF) Age >18 Exclusion Criteria: Open fractures Pathologic fractures Concomitant ipsilateral upper extremity fracture (not including distal ulna) Medical contraindication to systemic glucocorticoids (insulin-dependent Diabetes mellitus, history of avascular necrosis, allergy) Narcotic dependence Women who are pregnant or breastfeeding

Sites / Locations

  • Indiana Hand to Shoulder Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Test Group

Control Group

Arm Description

Test Group will receive 10mg intravenous dexamethasone at the time of incision, administered by the assigned anesthesiologist. Post-surgery, Test Group patients will be prescribed a 6-day oral methylprednisolone taper course.

Standard of care with no placebo

Outcomes

Primary Outcome Measures

Range of Motion
Active and Passive degrees of flexion, extension in the wrist. Forearm degrees of supination and pronation

Secondary Outcome Measures

Visual Analogue Scale (VAS) Pain
patient rates pain on a visual scale from no pain to worst possible pain

Full Information

First Posted
December 6, 2022
Last Updated
December 14, 2022
Sponsor
Indiana Hand to Shoulder Center
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1. Study Identification

Unique Protocol Identification Number
NCT05655130
Brief Title
Distal Radius Steroid
Official Title
Effects of Peri-Operative Glucosteroid Administration on Outcomes Following Distal Radius Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana Hand to Shoulder Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary goal of this study is to compare functional outcomes (range of motion [flexion, extension, supination, pronation], return to work, of patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. Secondary goals include comparison of pain control (number of pain pills consumed, visual analog scale (VAS) pain scores) between patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. The primary endpoint of this study will occur when 18 patients in each test-group complete the 6 month follow up visit for study.
Detailed Description
This will be a prospective, randomized, partially blinded, controlled trial where patients are randomized in a centralized fashion into 2 groups: a) Control group with no intraoperative glucocorticoids administered or b) Test group with administration of 10 mg glucocorticoids intraoperatively followed with a 6-day oral methylprednisolone taper course prescribed as a Medrol Dose Pack. Each group will enroll 30 patients for a study total of 60 over approximately a one year enrollment period. Randomization will be set up using sealedenvelope.com simple randomizer. The randomization process will ensure balance between both arms based on sex and age of patients enrolled. All patients scheduled for distal radius ORIF will be screened to meet inclusion/exclusion criteria. Patients will be randomized preoperatively by the research coordinator, based on a 1:1 weighting, upon obtaining to consent to either Control or Test group. Post-op therapists will be blinded to the patient treatment group until completion of protocol activities for each patient. After surgery, patients will be followed for a duration of at least 6 months. Interval follow-up information will be collected at 10 days, 6 weeks, 3 months, and 6 months. 3-view wrist radiographs will be taken at each follow-up visit.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm Description
Test Group will receive 10mg intravenous dexamethasone at the time of incision, administered by the assigned anesthesiologist. Post-surgery, Test Group patients will be prescribed a 6-day oral methylprednisolone taper course.
Arm Title
Control Group
Arm Type
Other
Arm Description
Standard of care with no placebo
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Intraoperative 10 mg IV Dose
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
The oral methylprednisolone taper course will begin on the day of surgery and will taper as noted below: Day 1: 24 mg orally (8 mg before breakfast; 4 mg after lunch; 4 mg after dinner; 8 mg at bedtime) Day 2: 20 mg orally (4 mg before breakfast; 4 mg after lunch; 4 mg after dinner; 8 mg at bedtime) Day 3: 16 mg orally (4 mg before breakfast; 4 mg after lunch; 4 mg after dinner; 4 mg at bedtime) Day 4: 12 mg orally (4 mg before breakfast; 4 mg after lunch; 4 mg at bedtime) Day 5: 8 mg orally (4 mg before breakfast; 4 mg at bedtime) Day 6: 4 mg orally (4 mg before breakfast)
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
standard of care surgery
Primary Outcome Measure Information:
Title
Range of Motion
Description
Active and Passive degrees of flexion, extension in the wrist. Forearm degrees of supination and pronation
Time Frame
comparison of 10 days to 6 months post-operative measurements
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) Pain
Description
patient rates pain on a visual scale from no pain to worst possible pain
Time Frame
6 Months
Other Pre-specified Outcome Measures:
Title
Return to Work
Description
comparison of patient's work schedule/limitations from baseline to 6 months (off study)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intra- or extra-articular distal radius fractures (AO 23-A2,3; 23B-1,2,3; 23C-1,2,3) treated with open reduction internal fixation (ORIF) Age >18 Exclusion Criteria: Open fractures Pathologic fractures Concomitant ipsilateral upper extremity fracture (not including distal ulna) Medical contraindication to systemic glucocorticoids (insulin-dependent Diabetes mellitus, history of avascular necrosis, allergy) Narcotic dependence Women who are pregnant or breastfeeding
Facility Information:
Facility Name
Indiana Hand to Shoulder Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Distal Radius Steroid

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