Distal Radius Steroid

Indiana Hand to Shoulder Center

Status and phase: Terminated; Phase 1

Conditions: Radius Fracture Distal; Fractures, Closed; Fractures, Bone

Treatments: Drug: Dexamethasone; Drug: Methylprednisolone; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05655130

R20180096

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Test Group

Experimental group

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.

Treatment:

Drug: Methylprednisolone

Drug: Dexamethasone

Control Group

Other group

Description:

Standard of care with no placebo

Treatment:

Other: Standard of Care