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

NCT06489626 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY24010173
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Arthritis Knee; Knee Osteoarthritis; Pain, Postoperative

Keywords

total knee arthroplasty; knee osteoarthritis; pain management

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Wound healing

  2-week, 6-week and 3-month postoperative visits

• Knee Injury and Osteoarthritis Outcome Scores

  2-week, 6-week and 3-month postoperative visits

Other Outcomes (1)

• Postoperative complications

  To occur at 30 and 90 days postoperatively

Study Arms (2)

Intraoperative and Post-operative steroid

EXPERIMENTAL

Patients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper

Drug: Methylprednisolone 4 milligram Tab; Drug: Dexamethasone injection

Intraoperative Steroid

ACTIVE COMPARATOR

Patients randomized to this group will only receive intraoperative intravenous dexamethasone

Drug: Dexamethasone injection

Interventions

Dexamethasone injection DRUG

4 milligram intravenous dexamethasone will be administered intraoperatively

Intraoperative Steroid; Intraoperative and Post-operative steroid

Methylprednisolone 4 milligram Tab DRUG

6-day 4 milligram methylprednisolone oral taper

Intraoperative and Post-operative steroid

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• F. Johannes Plate: lead

Study Sites (2)

UPMC East

Monroeville, Pennsylvania, 15146, United States

Location

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (2)

• 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.

  PMID: 38316236 BACKGROUND

• 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.

  PMID: 36058564 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative; Agnosia

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Johannes F Plate

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research Division of Adult Reconstruction

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)