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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
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:

- 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.

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.	NCT06489626
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 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	F. Johannes Plate
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Johannes F Plate
Principal Investigator Affiliation	University of Pittsburgh
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthritis Knee, Knee Osteoarthritis, Pain, Postoperative

Arms & Interventions

Arms

Experimental: Intraoperative and Post-operative steroid

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

Active Comparator: Intraoperative Steroid

Patients randomized to this group will only receive intraoperative intravenous dexamethasone

Interventions

Drug: - Methylprednisolone 4 milligram Tab

6-day 4 milligram methylprednisolone oral taper

Drug: - Dexamethasone injection

4 milligram intravenous dexamethasone will be administered intraoperatively

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.

UPMC East, Monroeville, Pennsylvania

Status

Address

UPMC East

Monroeville, Pennsylvania, 15146

Site Contact

Johannes F Plate, MD, PhD

[email protected]

443-691-2377

UPMC Shadyside Hospital, Pittsburgh, Pennsylvania

Status

Address

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232

Site Contact

Johannes F Plate, MD, PhD

[email protected]

443-691-2377

Clinical Trial Finder