Post-operative Methylprednisolone Taper Course for Orthopedic Surgery

Conditions

• Orthopedic Surgeries

Eligibility Criteria

Sex

ALL

Age

18 Years - 95 Years

Healthy Volunteers

Not accepted

Interventions

• 10 mg IV dexamethasone & 6 day oral methylprednisolone taper — DRUG
  Drug: 6-day oral methylprednisolone (glucocorticoid) taper course The oral methylprednisolone taper course will begin on the day of surgery and will include 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day. Drug:10 mg intravenous (IV) dexamethasone
• 10 mg IV dexamethasone — OTHER
  Drug:10 mg intravenous (IV) dexamethasone

Study Details

The clinical trial is a prospective randomized control trial of a group of patients undergoing surgical management of common orthopedic pathologies including fractures of the upper extremity and shoulder arthroplasty; arthritis surgeries (ex. carpometacarpal arthroplasty), release of compressive neuropathies (ex. carpal tunnel surgery), tendon procedures (ex. tendon repair), patients undergoing total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee. Patients will be assigned randomly to one of two treatment arms: (1) single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care) or (2) single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course (Active Group). The purpose of this study is to study the efficacy of a post-operative course of glucocorticoids (GCs like Methylprednisolone) on pain, nausea and range of motion after surgical management of common orthopedic upper extremity pathologies, including fractures of the upper extremity and shoulder arthroplasty and patients undergoing total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee.

Key Dates

Start date

Sep 7, 2018

Status verified

Mar 2026

Primary completion

Jan 31, 2029

Completion

Jan 31, 2029

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Methylprednisolone Treated Group
  Subjects in this group will receive single intraoperative course of 10 mg IV dexamethasone \& 6 day oral methylprednisolone taper that is 10 mg Intravenous IV dexamethasone and 6 day oral methylprednisolone taper course
• Other: Control Group
  Subjects in this group will receive single intraoperative dose of 10 mg IV dexamethasone; that is 10 mg Intravenous (IV) dexamethasone

Primary Outcome Measure

Change in post-operative pain scores using numeric verbal analogue scores (VAS-Pain) during follow up in the methylprednisolone treated group compared to the control group [ Time Frame: Post Operative day (1-15), 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively ]

Locations (3)

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