Clinical Trial

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

Active, Not Recruiting Phase 4
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Record status
This record was last updated October 6, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2019-09-06; most recent amendment 2025-10-01.
Status change: Recruiting → Active, Not Recruiting 2024-08-20
Status change: Not Yet Recruiting → Recruiting 2019-10-25
Trial Details
NCT Number NCT04082533
Lead Sponsor Hospital for Special Surgery, New York
Conditions Pain, Arthrofibrosis, Osteoarthritis, Knee
Enrollment 132 participants
Start Date 2019-07-24
Primary Completion 2026-05 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-10-06