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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Treatments: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Criteria

Inclusion Criteria:

• Elective primary unilateral total knee arthroplasty

• Osteoarthritis (OA) within the affected joint

• Patients of surgeons who have agreed to participate in the study

• Age ≥18 to 83 years

• American Society of Anesthesiologists (ASA) Physical Status 1-3

• Neuraxial Anesthesia

• Adductor canal block (ACB), Interspace between the popliteal artery and capsule of the posterior knee (IPACK) block (unless valgus knee patient), and Periarticular Injection (PAI) for postoperative pain

Exclusion Criteria:

• Contraindication to regional anesthesia, non-steroidal anti-inflammatory drugs, or steroids

• Pre-operative oral steroid use in the past 3 months

• Body mass index (BMI) greater than or equal to 45

• Intraarticular steroid injections within two months of scheduled surgery in affected joint

• Non-English speaking

• Pre-existing diagnosis of rheumatic disease, autoimmune disease, or immunodeficiency (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)

• Active infection

• History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids within one year

• Pregnant women

• Previous study participants in this study

• Type II Diabetes on insulin

• History of refractory postoperative nausea and vomiting (PONV) or PONV after sedation (can include if nausea only after general anesthesia)

• Previous hardware in affected joint

• Open Reduction and Internal Fixation (ORIF) surgery to affected joint

• Cementless total knee arthroplasty (TKA)