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

NCT ID: NCT06489626

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intraoperative and Post-operative steroid

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

Group Type: EXPERIMENTAL

Methylprednisolone 4 milligram Tab

Intervention Type: DRUG

6-day 4 milligram methylprednisolone oral taper

Dexamethasone injection

Intervention Type: DRUG

4 milligram intravenous dexamethasone will be administered intraoperatively

Intraoperative Steroid

Patients randomized to this group will only receive intraoperative intravenous dexamethasone

Group Type: ACTIVE_COMPARATOR

Dexamethasone injection

Intervention Type: DRUG

4 milligram intravenous dexamethasone will be administered intraoperatively

Interventions

Methylprednisolone 4 milligram Tab

6-day 4 milligram methylprednisolone oral taper

Intervention Type: DRUG

Dexamethasone injection

4 milligram intravenous dexamethasone will be administered intraoperatively

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

F. Johannes Plate

OTHER

Sponsor Role: lead

Responsible Party

F. Johannes Plate

Director of Research Division of Adult Reconstruction

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johannes F Plate

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC East

Monroeville, Pennsylvania, United States

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Johannes F Plate, MD, PhD

Role: CONTACT

platefj2@upmc.edu

4436912377

Logan Finger, MD

Role: CONTACT

lef65@pitt.edu

Facility Contacts

Johannes F Plate, MD, PhD

Role: primary

platefj2@upmc.edu

4436912377

Logan E Finger, MD

Role: backup

lef65@pitt.edu

Johannes F Plate, MD, PhD

Role: primary

platefj2@upmc.edu

4436912377

Logan E Finger, MD

Role: backup

lef65@pitt.edu

References

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.

Reference Type: BACKGROUND

PMID: 38316236 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36058564 (View on PubMed)

Other Identifiers

STUDY24010173

Identifier Type: -

Identifier Source: org_study_id