drugset / Trial / NCT04082533

Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)

NCT04082533

Phase 4 Active not recruiting 132 enrolled Hospital for Special Surgery, New York
RandomizedParallel-groupTriple-blindTreatment

Summary

In this study, total knee replacement patients will be determined to be stiff or non-stiff preoperatively. Stiffness designation is determined by preoperative range of motion (if flexion is \< 100 degrees, or extension lag is \> 10 degrees). The stiff and non-stiff groups will both be randomized to two groups to receive either intravenous hydrocortisone or a placebo at 3 intervals postoperatively. Patients will be followed up with in hospital and via the phone on postoperative day (POD) 1 and 2, as well as 6 weeks, 6 months, 1 year, and 2 years postoperatively. Patients will also have blood drawn preoperatively in the OR, on POD1, at their 6 week followup, and at their 1 and 2 year follow ups. This blood will be processed and analyzed.

Timeline

Start
2019-07-24
Primary completion
2026-05
Completion
2026-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrocortisone Other / unclassified 100 mg Intravenous

Indications