Post-operative Methylprednisolone Taper Course for Orthopedic Surgery

NCT ID: NCT03661645

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-07
• Study Completion Date: 2029-01-31

Brief Summary

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.

Detailed Description

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 500 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

Conditions

Orthopedic Surgeries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

10 mg IV dexamethasone & 6 day oral methylprednisolone taper

Intervention Type: 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

Control Group

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

Group Type: OTHER

10 mg IV dexamethasone

Intervention Type: OTHER

Drug:10 mg intravenous (IV) dexamethasone

Interventions

10 mg IV dexamethasone & 6 day oral methylprednisolone taper

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

Intervention Type: DRUG

10 mg IV dexamethasone

Drug:10 mg intravenous (IV) dexamethasone

Intervention Type: OTHER

Other Intervention Names

Medrol, Depo-Medrol, Solu-Medrol, A-Methapred; Decadron, Dexasone, Diodex, Hexadrol, Maxidex; Decadron, Dexasone, Diodex, Hexadrol, Maxidex

Eligibility Criteria

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 of Emory Hand Surgeons undergoing surgery for upper extremity arthritis (ex. carpometacarpal arthroplasty)
• Patients of Emory Hand Surgeons undergoing release for upper extremity compressive neuropathies (ex. carpal tunnel surgery)
• Patients of Emory Hand Surgeons undergoing procedures for upper extremity tendon pathologies (ex. tendon repair)
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Michael Gottschalk

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Gottschalk, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Clinic A, Clifton Road Clinic

Atlanta, Georgia, United States

21 Ortho Lane

Atlanta, Georgia, United States

Emory Healthcare Orthopaedics and Spine Center

Atlanta, Georgia, United States

Countries

United States

References

Wagner ER, Hussain ZB, Karzon AL, Cooke HL, Toston RJ, Hurt JT, Dawes AM, Gottschalk MB. Methylprednisolone taper is an effective addition to multimodal pain regimens after total shoulder arthroplasty: results of a randomized controlled trial: 2022 Neer Award winner. J Shoulder Elbow Surg. 2024 May;33(5):985-993. doi: 10.1016/j.jse.2023.12.016. Epub 2024 Feb 4.

Reference Type: DERIVED

PMID: 38316236 (View on PubMed)

Other Identifiers

IRB00104310

Identifier Type: -

Identifier Source: org_study_id