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Distal Radius Steroid

NCT05655130 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-23

No results posted yet for this study

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.

Conditions

  • Fractures, Bone
  • Fractures, Closed
  • Radius Fracture Distal

Interventions

DRUG

Dexamethasone

Intraoperative 10 mg IV Dose

DRUG

Methylprednisolone

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)

OTHER

Standard of Care

standard of care surgery

Sponsors & Collaborators

  • Indiana Hand to Shoulder Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2023-05-02
Completion
2023-05-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05655130 on ClinicalTrials.gov