Distal Radius Steroid

NCT ID: NCT05655130

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-06
• Study Completion Date: 2023-05-02

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.

Conditions

Fractures, Bone; Fractures, Closed; Radius Fracture Distal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test Group

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.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

Intraoperative 10 mg IV Dose

Methylprednisolone

Intervention Type: 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)

Control Group

Standard of care with no placebo

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

standard of care surgery

Interventions

Dexamethasone

Intraoperative 10 mg IV Dose

Intervention Type: 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)

Intervention Type: DRUG

Standard of Care

standard of care surgery

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana Hand to Shoulder Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

R20180096

Identifier Type: -

Identifier Source: org_study_id