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Corticosteroid

Methylprednisolone Taper for Post-Orthopedic Surgery Recovery

Phase 4

Waitlist Available

Led By Michael Gottschalk, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients of Emory Hand Surgeons undergoing surgery for upper extremity arthritis (ex. carpometacarpal arthroplasty)

Between the ages of 18 years and 95 years

Must not have

Patients with local infections

Women who are pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post operative day (1-7), 2 weeks, 6 weeks, and 12 weeks postoperatively

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether a 6-day course of oral methylprednisolone, given after a single dose of dexamethasone, is more effective than dexamethasone alone in reducing pain, nausea, and improving range of motion after surgery.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects include increased risk of infection due to immune suppression by steroids (glucocorticoids), blood sugar levels changes which could affect diabetics more severely and potential stomach irritation that might lead to ulcers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having surgery for hand arthritis at Emory.

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I am between 18 and 95 years old.

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I am having a hip replacement due to hip arthritis.

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I am having a knee replacement due to arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have a local infection.

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I am currently pregnant.

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I have serious injuries to other bones or organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post operative day (1-7), 2 weeks, 6 weeks, and 12 weeks postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post operative day (1-7), 2 weeks, 6 weeks, and 12 weeks postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and post operative day (1-7), 2 weeks, 6 weeks, and 12 weeks postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Range of Motion (ROM) prior to surgery and during follow up in the methylprednisolone treated group compared to the control group

Change in post-operative nausea scores using numeric verbal analogue scores (VAS-Nausea) during follow up in the methylprednisolone treated group compared to the control group

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

+2 more

Secondary study objectives

Methylprednisolone

Change in Short Form Health Survey (SF-12) scores during follow up in the methylprednisolone treated group compared to the control group

Change in post operative Patient-Rated Wrist Evaluation (PRWE) scores during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for upper extremity injuries

+3 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 7Eligibility criteria met