Distal Radius Steroid

Sponsor

Indiana Hand to Shoulder Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05655130

Collaborator

(none)

Enrollment

Location

Arms

60.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fractures, Bone Fractures, Closed Radius Fracture Distal	Drug: Dexamethasone Drug: Methylprednisolone Other: Standard of Care	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Peri-Operative Glucosteroid Administration on Outcomes Following Distal Radius Fracture

Actual Study Start Date :

Nov 6, 2018

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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: Control Group Standard of care with no placebo	Other: Standard of Care standard of care surgery

Arm

Intervention/Treatment

Experimental: 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.

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: Control Group

Standard of care with no placebo

Other: Standard of Care

standard of care surgery

Outcome Measures

Primary Outcome Measures

Range of Motion [comparison of 10 days to 6 months post-operative measurements]
Active and Passive degrees of flexion, extension in the wrist. Forearm degrees of supination and pronation

Secondary Outcome Measures

Visual Analogue Scale (VAS) Pain [6 Months]
patient rates pain on a visual scale from no pain to worst possible pain

Other Outcome Measures

Return to Work [6 months]
comparison of patient's work schedule/limitations from baseline to 6 months (off study)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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