An Oral Methylprednisolone Taper Within a Multimodal Analgesic Regimen After Total Knee Arthroplasty: a Double-Blind Randomized Placebo-Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to evaluate the efficacy of an oral methylprednisolone taper on acute postoperative pain, function, opioid consumption, nausea, and complications following outpatient total knee arthroplasty (TKA). We hypothesize that administration of an oral methylprednisolone taper starting on postoperative day 1 (POD 1) following TKA will be associated with improved pain and decreased opioid use, nausea, and complications at POD1-7, as compared to similar patients who receive placebo. Additionally, those taking methylprednisolone will report decreased pain and greater objective functional outcomes at 3 and 6 weeks postoperatively as compared to controls.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Any patient undergoing primary TKA with a diagnosis of osteoarthritis

• •≥ 18 years old

• Willingness to undergo randomization

Locations
United States
Illinois
Rush Oak Brook Outpatient Center
RECRUITING
Oak Brook
Contact Information
Primary
Anne DeBenedetti
anne.debenedetti@rushortho.com
3124322468
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 420
Treatments
Experimental: Methylprednisolone taper
Methylprednisolone taper - 21 x 4mg tablets beginning on POD 1
Placebo_comparator: Placebo taper
2.Placebo taper - 21 sugar tablets beginning on POD 1 with standard management
Related Therapeutic Areas
Sponsors
Leads: Rush University Medical Center

This content was sourced from clinicaltrials.gov