Methylprednisolone Taper for Post-Orthopedic Surgery Recovery

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byMichael Gottschalk, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 18-95 undergoing certain orthopedic surgeries, like joint replacements or tendon repairs. It's not for those with significant other injuries, infections, minors, substance abuse history, severe heart disease, kidney/liver issues, active ulcers, diabetic neuropathy, rheumatoid arthritis affecting pain perception or pregnant women.

Inclusion Criteria

I am having surgery for a tendon issue in my arm or hand.

I am having surgery for an upper limb fracture and agree to join the study.

Patients willing and able to provide written and informed consent

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Exclusion Criteria

I am currently pregnant.

I do not have a history of substance abuse, severe allergies, heart, kidney, liver issues, stomach ulcers, diabetic nerve damage, arthritis, or mental health conditions that could affect pain perception.

Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

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Treatment Details

Interventions

Dexamethasone (Corticosteroid)
Methylprednisolone (Corticosteroid)

Trial OverviewThe study tests if a post-operative steroid taper (methylprednisolone) after an IV dose of dexamethasone improves pain control and motion compared to just the IV dose. Patients are randomly assigned to either the standard care group or the group receiving additional oral steroids.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Control GroupExperimental Treatment1 Intervention

Subjects in this group will receive single intraoperative dose of 10 mg IV dexamethasone; that is 10 mg Intravenous (IV) dexamethasone

Group II: Methylprednisolone Treated GroupActive Control1 Intervention

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

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Dexamethasone for: