RECRUITING

Medrol Dosepak for Outpatient Total Knee Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05097976

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any patient undergoing primary TKA with a diagnosis of osteoarthritis
  2. * Willingness to undergo randomization
  1. * Reported chronic corticosteroid or opiate use
  2. * Suspected or confirmed periprosthetic joint infection
  3. * Revision TKA
  4. * Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, or post-traumatic arthritis
  5. * American Society of Anesthesiologists (ASA) score ≥ 4
  6. * Reported history of liver disease, renal disease, or diabetes mellitus
  7. * Current systemic fungal infection or other local infection
  8. * Immunocompromised or immunosuppressed
  9. * Current peptic ulcer disease
  10. * History of hypothyroidism, psychosis, heart failure, myasthenia gravis, ocular herpes simplex virus, or systemic sclerosis
  11. * Women with reported current pregnancy
  12. * Known hypersensitivity to methylprednisolone
  13. * Inability to take oral medications
  14. * Unable to provide consent

Contacts and Locations

Study Contact

Anne DeBenedetti
CONTACT
3124322468
anne.debenedetti@rushortho.com

Principal Investigator

Craig Della Valle, MD
PRINCIPAL_INVESTIGATOR
Rush University Medical Center

Study Locations (Sites)

Rush Oak Brook Outpatient Center
Oak Brook, Illinois, 60523
United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

  • Craig Della Valle, MD, PRINCIPAL_INVESTIGATOR, Rush University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Methylprednisolone
  • acute postoperative pain
  • acute function
  • opioid consumption
  • complications following total knee arthroplasty

Additional Relevant MeSH Terms

  • Total Knee Arthroplasty