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

Phase 4

Active, not recruiting

• Conditions: Pain; Arthrofibrosis; Osteoarthritis, Knee

• Registration Number: NCT04082533
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-6-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Inclusion Criteria:<br><br> - Elective primary unilateral total knee arthroplasty<br><br> - Osteoarthritis (OA) within the affected joint<br><br> - Patients of surgeons who have agreed to participate in the study<br><br> - Age =18 to 83 years<br><br> - American Society of Anesthesiologists (ASA) Physical Status 1-3<br><br> - Neuraxial Anesthesia<br><br> - Adductor canal block (ACB), Interspace between the popliteal artery and capsule of<br> the posterior knee (IPACK) block (unless valgus knee patient), and Periarticular<br> Injection (PAI) for postoperative pain<br><br>Exclusion Criteria:<br><br> - Contraindication to regional anesthesia, non-steroidal anti-inflammatory drugs, or<br> steroids<br><br> - Pre-operative oral steroid use in the past 3 months<br><br> - Body mass index (BMI) greater than or equal to 45<br><br> - Intraarticular steroid injections within two months of scheduled surgery in affected<br> joint<br><br> - Non-English speaking<br><br> - Pre-existing diagnosis of rheumatic disease, autoimmune disease, or immunodeficiency<br> (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease,<br> multiple sclerosis, Type I diabetes)<br><br> - Active infection<br><br> - History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids<br> within one year<br><br> - Pregnant women<br><br> - Previous study participants in this study<br><br> - Type II Diabetes on insulin<br><br> - History of refractory postoperative nausea and vomiting (PONV) or PONV after<br> sedation (can include if nausea only after general anesthesia)<br><br> - Previous hardware in affected joint<br><br> - Open Reduction and Internal Fixation (ORIF) surgery to affected joint<br><br> - Cementless total knee arthroplasty (TKA)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative Range of Motion (ROM)

Secondary Outcome Measures

Name	Time	Method
Postoperative Stiffness;Numeric Rating Scale (NRS);PainDETECT Neuropathic Pain Score;Opioid consumption;Knee injury and Osteoarthritis Outcome Score (KOOS Jr.);Lower extremity Activity Survey (LEAS) scores;Veterans Rand 12-item health survey (VR-12) score;TIme to physical therapy goals completion;Inflammatory state (via protein, ribonucleic acid (RNA), cellular, and tissue level analyses;MRI Findings;Biomechanical findings