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

Phase 4

Not yet recruiting

• Conditions: Arthritis Knee; Knee Osteoarthritis; Pain, Postoperative
• Interventions: Drug: Methylprednisolone 4 milligram Tab; Drug: Dexamethasone injection

• Registration Number: NCT06489626
• Lead Sponsor: F. Johannes Plate

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-12
• Last Update Posted: 2025-04-15
• Study Start: 2025-08-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraoperative and Post-operative steroid	Methylprednisolone 4 milligram Tab	Patients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper
Intraoperative Steroid	Dexamethasone injection	Patients randomized to this group will only receive intraoperative intravenous dexamethasone
Intraoperative and Post-operative steroid	Dexamethasone injection	Patients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper

Primary Outcome Measures

Name	Time	Method
Prescription narcotic usage	daily for two weeks	Oral morphine equivalent units will be collected based on patient usage of prescribed narcotic pain medication
Daily Pain at rest and with movement	daily for two weeks	numeric rating scale from 0 to 10 (0=minimal, 10=maximal) will be used to capture patient experienced pain
Sleep disturbance	daily for two weeks	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
Knee Range of motion	2-week, 6-week and 3-month postoperative visits	goniometric measurement of knee extension and flexion

Secondary Outcome Measures

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

Trial Locations

Locations (2)

UPMC East; 🇺🇸 Monroeville, Pennsylvania, United States

UPMC Shadyside Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States