Methylprednisolone Taper, Lower Extremity

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Total knee replacement surgery is a commonly performed and widely successful surgery to improve mobility and decrease pain in patients suffering from severe knee arthritis. However, in the immediate period after knee replacement, patients often experience significant pain and nausea, which can limit early recovery after surgery. Glucocorticoids are anti-inflammatory drugs that can reduce pain and swelling by blocking the inflammatory process, and have already shown promise in various surgical settings, including after knee replacement. There are different glucocorticoid formulations available, and in this particular study, we are evaluating the effects of administering a Medrol Dose Pak, which is a commonly available glucocorticoid taper that is administered over a short period of time after surgery. Our hypothesis is that the administration of the Medrol Dose Pak will lead to decreased pain, nausea, and opioid consumption in the weeks following total knee replacement.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.

• Patients of the ages of 18 and 95 years.

Exclusion Criteria:

• Patients with concurrent and significant injuries to other bones or organs.

• Minors unable to consent for participation in the study.

• Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.

• Patients with pre-existing immune suppression, where further immune suppression with glucocorticoids could warrant unwarranted or unneeded risk.