Methylprednisolone Taper After Total Knee Replacement

NCT ID: NCT05859269

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2025-07-23

Brief Summary

Total knee replacement surgery is a commonly performed and widely successful surgery to improve mobility and decrease pain in patients suffering from severe knee arthritis. However, in the immediate period after knee replacement, patients often experience significant pain and nausea, which can limit early recovery after surgery. Glucocorticoids are anti-inflammatory drugs that can reduce pain and swelling by blocking the inflammatory process, and have already shown promise in various surgical settings, including after knee replacement. There are different glucocorticoid formulations available, and in this particular study, we are evaluating the effects of administering a Medrol Dose Pak, which is a commonly available glucocorticoid taper that is administered over a short period of time after surgery. Our hypothesis is that the administration of the Medrol Dose Pak will lead to decreased pain, nausea, and opioid consumption in the weeks following total knee replacement.

Detailed Description

The study aims to evaluate the efficacy of a post-operative course of glucocorticoids on pain, range of motion, and extremity function after total knee replacement surgery. The goal is to compare the effects of a Medrol dose pak administration to the standard of care, which includes a single intraoperative dose of 10 mg intravenous dexamethasone, on postoperative outcomes. The study is important in the field because it aims to evaluate the effectiveness of glucocorticoids in reducing pain, nausea, and opioid consumption following total knee replacement surgery. The study will provide valuable insight into the role and optimal dosing of oral glucocorticoids after total knee replacement surgery (TKA). The results of this study could potentially improve postoperative outcomes for patients undergoing TKA. The study population in this randomized control trial consists of patients undergoing total knee replacement surgery. Patients will be randomly assigned to one of two treatment arms: (1) a single intraoperative dose of 10 mg intravenous dexamethasone (control group) or (2) a single intraoperative dose of 10 mg intravenous dexamethasone followed by a 6-day oral methylprednisolone taper course. The study does not mention any populations of increased concern. The study will last approximately 6 months with encounters at normal times within the clinic. The Emory r extremity surgeons will personally contact all patients for 1-day post-operation (standard of care for them) and at 7-10 days. Recruitment will occur at Emory University Orthopaedics & Spine Hospital. The study team will enroll 100 patients per group - 200 total.

Conditions

Knee Arthritis

Study Design

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

Study Groups

Experimental Group: Medrol Dose

The perioperative Medrol dose treatment will consist of a course that lasts six days, with 24 milligrams administered on the first day, 20 milligrams on the second day, 60 milligrams on the third day, 12 milligrams on the fourth day, 8 milligrams on the fifth day, and 4 milligrams on the sixth day. Patients will then be followed up at the clinic for six weeks following their procedure to allow for clinical evaluation and to measure outcome variables.

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: DRUG

Patients will receive a single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course.

Patients will also receive a standardized multimodal postoperative pain management regimen which includes nonsteroidal anti-inflammatory medication (e.g., NSAIDs) and opioid pain medications, both in the hospital and at home as part of standard care.

Control Group: Standard of Care

Patients in this group will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care).

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Patients will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care).

Patients will also receive a standardized multimodal postoperative pain management regimen which includes nonsteroidal anti-inflammatory medication (e.g., NSAIDs) and opioid pain medications, both in the hospital and at home as part of standard care.

Interventions

Methylprednisolone

Patients will receive a single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course.

Patients will also receive a standardized multimodal postoperative pain management regimen which includes nonsteroidal anti-inflammatory medication (e.g., NSAIDs) and opioid pain medications, both in the hospital and at home as part of standard care.

Intervention Type: DRUG

Standard of Care

Patients will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care).

Patients will also receive a standardized multimodal postoperative pain management regimen which includes nonsteroidal anti-inflammatory medication (e.g., NSAIDs) and opioid pain medications, both in the hospital and at home as part of standard care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
• Patients of the ages of 18 and 95 years.

Exclusion Criteria

• Patients with concurrent and significant injuries to other bones or organs.
• Minors unable to consent for participation in the study.
• Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
• Patients with pre-existing immune suppression, where further immune suppression with glucocorticoids could warrant unwarranted or unneeded risk.

• 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

Ajay Premkumar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ajay Premkumar, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Musculoskeletal Institute

Atlanta, Georgia, United States

Emory University Orthopaedics & Spine Hospital

Tucker, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00005985

Identifier Type: -

Identifier Source: org_study_id