Methylprednisolone for Knee Arthritis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJohannes F Plate

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: F. Johannes Plate

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with knee arthritis who have undergone total knee arthroplasty. Participants should be interested in improving postoperative pain and range of motion. Specific inclusion and exclusion criteria are not provided, but typically would involve age, overall health status, and absence of conditions that could interfere with the study.

Inclusion Criteria

Access to computer or smartphone for completion of REDCap surveys

I am recommended to have a total knee replacement.

Exclusion Criteria

I am on long-term steroid medication.

Immunosuppressed patients

Known diabetic patients with an HgbA1c >6.5 preoperatively

+8 more

Participant Groups

The study tests if a tapering dose of methylprednisolone after surgery can improve functional outcomes compared to just using dexamethasone during surgery. A taper involves starting with a high dose then gradually reducing it over several days.

2Treatment groups

Experimental Treatment

Active Control

Group I: Intraoperative and Post-operative steroidExperimental Treatment2 Interventions

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

Group II: Intraoperative SteroidActive Control1 Intervention

Patients randomized to this group will only receive intraoperative intravenous dexamethasone

Methylprednisolone is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Medrol for: