Distal Radius Steroid

NCT05655130 | Terminated Phase 1 FDA Drug

• 1 other identifier: R20180096
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Bone; Fractures, Closed; Radius Fracture Distal

Outcome Measures

Primary Outcomes (1)

• Range of Motion

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

  comparison of 10 days to 6 months post-operative measurements

Secondary Outcomes (1)

• Visual Analogue Scale (VAS) Pain

  6 Months

Other Outcomes (1)

• Return to Work

  6 months

Study Arms (2)

Test Group

EXPERIMENTAL

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.

Drug: Dexamethasone; Drug: Methylprednisolone

Control Group

OTHER

Standard of care with no placebo

Other: Standard of Care

Interventions

Dexamethasone DRUG

Intraoperative 10 mg IV Dose

Test Group

Methylprednisolone DRUG

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)

Test Group

Standard of Care OTHER

standard of care surgery

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana Hand to Shoulder Center: lead

Study Sites (1)

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

MeSH Terms

Conditions

Fractures, Bone; Fractures, Closed; Wrist Fractures

Interventions

Dexamethasone; Methylprednisolone; Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries; Wrist Injuries; Arm Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 19, 2022
• Study Start: November 6, 2018
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)