The Effect of a Methylprednisolone Taper on Outcomes Following Total Knee Arthroplasty

Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. This study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. A taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.

Study Overview

• Status: Withdrawn
• Conditions: Pain, Postoperative; Knee Osteoarthritis; Arthritis Knee
• Intervention / Treatment: Drug: Methylprednisolone 4 milligram Tab; Drug: Dexamethasone injection

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • UPMC East
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Shadyside Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients indicated for primary total knee arthroplasty.
• Access to computer or smartphone for completion of REDCap surveys

Exclusion Criteria:

• Patients less than 18 years of age, patients unable to consent, known diabetic patients and those with an HgbA1c >6.5 preoperatively, patients who are on chronic steroid treatments, patients with chronic pain on opioid management, patients with allergies to steroids, patients with a history of peptic ulcer disease, patients with a history of heart failure and patients with a history of renal and/or hepatic failure will be excluded. Those that are immunosuppressed as well as pregnant and/or lactating will also be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoperative and Post-operative steroid; Patients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper	Drug: Methylprednisolone 4 milligram Tab; 6-day 4 milligram methylprednisolone oral taper; Drug: Dexamethasone injection; 4 milligram intravenous dexamethasone will be administered intraoperatively
Active Comparator: Intraoperative Steroid; Patients randomized to this group will only receive intraoperative intravenous dexamethasone	Drug: Dexamethasone injection; 4 milligram intravenous dexamethasone will be administered intraoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Pain at rest and with movement	numeric rating scale from 0 to 10 (0=minimal, 10=maximal) will be used to capture patient experienced pain	daily for two weeks
Prescription narcotic usage	Oral morphine equivalent units will be collected based on patient usage of prescribed narcotic pain medication	daily for two weeks
Sleep disturbance	Patients will be asked if pain caused them to be awoken in the night and if so what level of pain they were experiencing at that time	daily for two weeks
Knee Range of motion	goniometric measurement of knee extension and flexion	2-week, 6-week and 3-month postoperative visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	Surgical site will be evaluated for normal wound healing	2-week, 6-week and 3-month postoperative visits
Knee Injury and Osteoarthritis Outcome Scores	Questionnaire assessing for function will be administered (0= extreme problems present, 100= no problems present)	2-week, 6-week and 3-month postoperative visits

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	All complications related to the patients procedure including infection, need for revision, emergency room visits, readmissions, etc. will be collected	To occur at 30 and 90 days postoperatively

Collaborators and Investigators

• Sponsor: F. Johannes Plate
• Investigators: Principal Investigator: Johannes F Plate, University of Pittsburgh

Publications and helpful links

General Publications

• 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.
• Gottschalk MB, Dawes A, Hurt J, Spencer C, Campbell C, Toston R, Farley K, Daly C, Wagner ER. A Prospective Randomized Controlled Trial of Methylprednisolone for Postoperative Pain Management of Surgically Treated Distal Radius Fractures. J Hand Surg Am. 2022 Sep;47(9):866-873. doi: 10.1016/j.jhsa.2022.06.008.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: knee osteoarthritis; total knee arthroplasty; pain management
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Neurobehavioral Manifestations; Osteoarthritis; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Osteoarthritis, Knee; Agnosia; Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Benzene Derivatives; Sulfonic Acids; Sulfur Acids; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Calcium Dobesilate
• Other Study ID Numbers: STUDY24010173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No