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ACTIVE NOT RECRUITING
NCT04082533
PHASE4

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

Sponsor: Hospital for Special Surgery, New York

View on ClinicalTrials.gov

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.

Official title: Effect of Intravenous Hydrocortisone on Range of Motion After Total Knee Arthroplasty: A Randomized Placebo-Controlled Trial With Nested Case-Control Study

Key Details

Gender

All

Age Range

18 Years - 83 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2019-07-24

Completion Date

2026-05

Last Updated

2025-10-06

Healthy Volunteers

Yes

Interventions

DRUG

Hydrocortisone

Patients will be receiving 100 mg intravenous hydrocortisone every 8 hours, starting in the holding area roughly 2 hours prior to first incision.

DRUG

Dextrose 5% in water (D5W)

Patients will be receiving a matched volume of D5W every 8 hours, starting in the holding area roughly 2 hours prior to first incision.

Locations (1)

Hospital for Special Surgery

New York, New York, United States