Post-operative Methylprednisolone Taper Course for Orthopedic Surgery



Status:Recruiting
Healthy:No
Age Range:18 - 95
Updated:9/19/2018
Start Date:September 7, 2018
End Date:January 2021
Contact:Michael Gottschalk, MD
Email:michael.gottschalk@emoryhealthcare.org
Phone:404-727-5658

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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; 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.

Reducing pain and improving function is of great importance in the immediate period after
surgery. Many orthopaedic procedures result in fluid build-up around the surgical site which
results in pain and decreased healing. Glucocorticoids are drugs that block the inflammatory
process which can decrease this pain and fluid build-up. Furthermore, glucocorticoids are
safe if given in low doses and for a short period of time. To help address this gap, the
study intend to give patients glucocorticoids after various upper extremity orthopedic
procedures; total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty
for osteoarthritis of the knee, assessing their pain and range of motion post-operatively.
The study hypothesize that glucocorticoids will result in less inflammation around the
surgical site, leading to pain relief, greater healing ability, and improvements in range of
motion of the injured joint.

The study aims to enroll 1000 subjects that are 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).
Subjects will be followed up in clinic 2, 6, and 12 weeks postoperatively that is a standard
of care for upper extremity fractures, shoulder arthroplasty, total hip arthroplasty for
osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee

Inclusion Criteria:

- Patients of Emory Hand Surgeons undergoing surgery for an upper extremity fracture who
are willing to participate in the study will be included in the study (Including
American Orthopedic(AO) and American Orthopaedic Trauma Association (OTA) AO/OTA
Classification 1, 2, and 7 +/- Type A, B, C).

- Patients of Emory Hand Surgeons undergoing Total Shoulder Arthroplasty or Reverse
Shoulder Arthroplasty who are willing to participate in the study will be included in
the study (Walsh Classification A-D).

- Patients undergoing total hip arthroplasty for osteoarthritis of the hip

- Patients undergoing total knee arthroplasty for osteoarthritis of the knee

- Between the ages of 18 years and 95 years.

- Patients willing and able to provide written and informed consent

Exclusion Criteria:

- Patients with concurrent and significant injuries to other bones or organs.

- Patients with local infections.

- Patients who are minors, vulnerable subjects, or who are not willing to consent to
participate in the study.

- History of alcohol or medical abuse, allergies to glucocorticoids, daily use of
glucocorticoids or chronic opioid use prior to the injury (morphine, fentanyl,
hydromorphone, ketobemidone, methadone, nico morphine, oxycodone, and meperidine),
history of severe heart disease ( New York Heart Association (NYHA 2)), renal failure,
or liver dysfunction, active peptic ulcer disease, diabetic neuropathy, rheumatoid
arthritis, and neurological or psychiatric diseases, potentially influencing pain
perception.

- Women who are pregnant

- Patients with pre-existing immune suppression, where further immune suppression with
GCs could warrant unwarranted or unneeded risk.

- Subjects who, in the opinion of the investigator, may be non-compliant with study
schedules or procedures.
We found this trial at
3
sites
Atlanta, Georgia 30329
Principal Investigator: Michael Gottschalk, MD
Phone: 404-727-5658
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Atlanta, GA
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Atlanta, Georgia 30322
Principal Investigator: Michael Gottschalk, MD
Phone: 404-727-5658
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30329
Principal Investigator: Michael Gottschalk, MD
Phone: 404-727-5658
?
mi
from
Atlanta, GA
Click here to add this to my saved trials