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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post operative day (1-7), 2 weeks, 6 weeks, and 12 weeks postoperatively
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,559,573 Total Patients Enrolled
Michael Gottschalk, MDPrincipal InvestigatorEmory University

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03661645 — Phase 4
Orthopedic Procedures Research Study Groups: Methylprednisolone Treated Group, Control Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to participants at the present time?

"Per the info on clinicaltrials.gov, this research is not currently enrolling patients; its initial posting date was September 7th 2018 and it was last updated February 25th 2022. However, 697 other studies are in need of participants at present."

Answered by AI

Is eligibility for this clinical trial restricted to individuals aged 80 or younger?

"The age range to be enrolled in this clinical trial is 18-95, as stipulated by the given eligibility criteria."

Answered by AI

What goals has this research endeavor set out to achieve?

"This clinical trial will monitor the post-operative Change in Numeric Verbal Analogue Scores (VAS-Nausea) of participants over a 7 day period, 2 weeks, 6 weeks and 12 weeks after the procedure. As secondary outcomes it considers changes to Knee Injury & Osteoarthritis Outcome Score (KOOS), patient's pain control satisfaction with the intervention as well as EuroQol 5 Dimensions score (EQ-5D). Ratings are based on numerical scales from 1 to 10 or 1 to 3 depending on outcome measures and evaluated before treatment and at regular intervals afterwards."

Answered by AI

What are the typical applications of Methylprednisolone Treated Group?

"Methylprednisolone Treated Group is usually administered to treat macular edema, and can be of help in managing eye-related issues, ulcerative colitis, as well as varicella-zoster virus acute retinal necrosis."

Answered by AI

What safety precautions have been taken for those who receive Methylprednisolone treatments?

"Clinical trials from Phase 4 have already given this treatment the green light, so our team at Power has rated Methylprednisolone Treated Group's safety as a 3 on a scale of 1 to 3."

Answered by AI

How many participants have been enrolled in this research study?

"Unfortunately, recruitment for this trial has closed as of February 25th 2021. Nevertheless, there are still 13 studies recruiting patients who have undergone orthopedic procedures and 684 trials requiring individuals treated with methylprednisolone to participate."

Answered by AI

Could I qualify to participate in this experiment?

"This trial is recruiting 1000 individuals aged 18-95 who have undergone orthopedic procedures, and must meet one of the following criteria: Patients undergoing an upper extremity fracture classified by AO/OTA Classification 1, 2, or 7 +/- Type A ,B,C; Walsh Classification A-D for Total Shoulder Arthroplasty or Reverse Shoulder Arthroplasty; carpometacarpal arthroplasty surgery due to arthritis in the upper extremities; release from compressive neuropathies located in the upper limb area (e.g carpal tunnel); tendon pathology treatment such as repair operations; total hip ar"

Answered by AI

What have previous investigations revealed regarding the Methylprednisolone Treated Group?

"Currently, there are 684 active trials for Methylprednisolone Treated Group with 176 in phase 3. Most of these studies are located in Duarte, California though the therapy is being researched at 23415 sites across the world."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Emory Healthcare Orthopaedics and Spine Center
Recent research and studies
clinicaltrials.govStudy
Post-operative Methylprednisolone Taper Course for Orthopedic Surgery
Michael Gottschalk 2018. "Post-operative Methylprednisolone Taper Course for Orthopedic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03661645.
All > Orthopedic
~107 spots leftby Jan 2025
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