Methylprednisolone Taper After Total Knee Replacement

NCT05859269 | Completed Phase 4 FDA Drug

• 1 other identifier: STUDY00005985
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Arthritis

Keywords

Methylprednisolone; Total Knee Replacement

Outcome Measures

Primary Outcomes (2)

• Changes in Pain Score during Follow up period

  A pain assessment will be assessed at each post-operative visit via the Visual Analog Pain Scale (VAS-pain), which is ranked from 0 (no pain) to 10 (highest amount of pain). Pain will be assessed at rest and during active movement of extremity. Patients will also be asked to fill out the VAS-pain score each day until post-op day 7.

  Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

• Changes in Nausea score during Follow Up Period

  : A nausea assessment will be assessed at each post-operative visit via the Visual Analog Nausea Scale (VAS-nausea), which is ranked from 0 (no nausea) to 10 (highest amount of nausea). Patients will be asked to fill out the VAS-nausea each day until post-operative day 7. Patients will also be monitored for post-operative vomiting.

  Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

Secondary Outcomes (4)

• Changes in the postoperative range of motion following total knee arthroplasty (TKA)

  Immediately before the surgery, Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

• Changes in post operative knee function utilizing Knee injury and Osteoarthritis Outcome Score (KOOS)

  Day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

• Compare patient satisfaction with acute postoperative pain control

  Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

• Compare the postoperative opiate consumption measured as the number of tablets taken

  Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

Study Arms (2)

Experimental Group: Medrol Dose

EXPERIMENTAL

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.

Drug: Methylprednisolone

Control Group: Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

Methylprednisolone 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.

Experimental Group: Medrol Dose

Standard of Care 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.

Control Group: Standard of Care

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory Musculoskeletal Institute

Atlanta, Georgia, 30329, United States

Location

Emory University Orthopaedics & Spine Hospital

Tucker, Georgia, 30084, United States

Location

MeSH Terms

Interventions

Methylprednisolone; Standard of Care

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ajay Premkumar, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: October 16, 2023
• Primary Completion: July 23, 2025
• Study Completion: July 23, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)