NCT05859269

Methylprednisolone Taper After Total Knee Replacement

Methylprednisolone Taper After Total Knee Replacement: A Prospective Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
OTHER	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.

Timeline

• Start date: 2023-10-16
• Primary completion: 2025-07-23
• Completion: 2025-07-23
• First posted: 2023-05-15
• Last updated: 2025-09-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study