Clinical Trial Finder

Oral Steroid Taper After Total Knee Arthroplasty

Study Purpose

This study aims to evaluate the effectiveness of an oral methylprednisolone taper in reducing postoperative pain, opioid consumption, and nausea following primary total knee arthroplasty (TKA).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Any patient undergoing primary TKA with a diagnosis of osteoarthritis.
  • - > 18 years old.
  • - Willingness to undergo randomization.
  • - Patients who will be home by postoperative day (POD) #1 to start the dosing schedule that day (includes both ambulatory and POD #1 discharge patients)

    Exclusion Criteria:

    - Reported chronic corticosteroid or opiate use prior to surgery.
  • - Prior Open Surgery on the Ipsilateral Knee.
  • - Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, septic arthritis, or postoperative traumatic arthritis.
  • - American Society of Anesthesiologists (ASA) score ≥ 4.
  • - Reported history of liver disease, renal disease, or diabetes mellitus.
  • - Current systemic fungal infection or other local infection.
  • - Immunocompromised or immunosuppressed.
  • - Current peptic ulcer disease.
  • - History of psychosis, heart failure, myasthenia gravis, ocular herpes simplex virus, or systemic sclerosis.
  • - Women with reported current pregnancy.
  • - Known hypersensitivity to methylprednisolone.
  • - ≤ 18 years old.
  • - Inability to take oral medications.
- Unable to provide consent

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT07070882
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Columbia University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Knee
Additional Details

This study aims to evaluate the effectiveness of an oral methylprednisolone taper in reducing postoperative pain, opioid consumption, and nausea following primary total knee arthroplasty (TKA). While intravenous (IV) corticosteroids have been shown to provide short-term pain relief in the immediate postoperative period, their effects are limited to the first 24 hours. Given the inflammatory nature of TKA recovery, extending steroid administration through an oral taper may provide additional benefits in pain control, opioid reduction, and functional recovery. This study will assess whether adding an oral steroid taper to standard multimodal pain management improves clinical outcomes in TKA patients.This prospective, single-blinded, randomized controlled trial will enroll adults aged 18 and older undergoing primary TKA for osteoarthritis at Columbia University Medical Center.

Arms & Interventions

Arms

Experimental: Patients receiving oral methylprednisolone

Patients receiving a six-day oral methylprednisolone taper (21 tablets, 4 mg each) in addition to standard multimodal pain management

No Intervention: Patients receiving standard pain management without the taper

Patients receiving standard pain management without the taper

Interventions

Drug: - Methylprednisolone

Patients will receive a tapered dose of methylprednisolone with the standard of care pain management

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbia University Medical Center, New York 5128581, New York 5128638

Status

Recruiting

Address

Columbia University Medical Center

New York 5128581, New York 5128638, 10032

Site Contact

Herbert John Cooper, MD

[email protected]

212-305-6959

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