Status:
ACTIVE_NOT_RECRUITING
Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Pain
Arthrofibrosis
Eligibility:
All Genders
18-83 years
Phase:
PHASE4
Brief 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 deg...
Detailed Description
TKA is the standard of care for treating patients suffering from end-stage knee arthritis and other disabling knee injuries. Indications have increased to ever younger patients and, combined with the ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04082533
Start Date
July 24 2019
End Date
May 1 2026
Last Update
October 6 2025
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021