Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)
Key facts
- Who runs it
- Hospital for Special Surgery, New York
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 4
- People taking part
- 65 people enrolled
- Started
- 24 Jul 2019
- Expected to end
- Jul 2027
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Hydrocortisone
- Dextrose 5% in water (D5W)
- Record updated
- 13 October 2026
Who can take part
- Age
- 18 years to 83 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- Contraindication to regional anesthesia, non-steroidal anti-inflammatory drugs, or steroids
- Pre-operative oral steroid use in the past 3 months
- Intraarticular steroid injections within two months of scheduled surgery in affected joint
- Previous study participants in this study
- Previous hardware in affected joint
- Open Reduction and Internal Fixation (ORIF) surgery to affected joint
- 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
- 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)
- Body mass index (BMI) greater than or equal to 45
- Non-English speaking
- Pregnant women
- Cementless total knee arthroplasty (TKA)
Where in United States
- Hospital for Special SurgeryNew York, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Stiffness Intravenous HydrocortisoneExisting treatment, for comparison
Total knee replacement patients with preoperative knee stiffness (defined as flexion \< 100 degrees or extension lag \> 10 degrees) receive 3 doses of 100mg intravenous hydrocortisone every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.
Treatment: Hydrocortisone
- Stiffness Intravenous PlaceboPlacebo, for comparison
Total knee replacement patients with preoperative knee stiffness (defined as flexion \< 100 degrees or extension lag \> 10 degrees) receive 3 doses of matched volume diluent every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.
Treatment: Dextrose 5% in water (D5W)
- Non-stiff Intravenous HydrocortisoneExisting treatment, for comparison
Total knee replacement patients without preoperative knee stiffness (defined as flexion \< 100 degrees or extension lag \> 10 degrees) receive 3 doses of 100mg intravenous hydrocortisone every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.
Treatment: Hydrocortisone
- Non-stiff Intravenous placeboPlacebo, for comparison
Total knee replacement patients without preoperative knee stiffness (defined as flexion \< 100 degrees or extension lag \> 10 degrees) receive 3 doses of matched volume diluent every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.
Treatment: Dextrose 5% in water (D5W)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Intravenous Hydrocortisone on Range of Motion After Total Knee Arthroplasty: A Randomized Placebo-Controlled Trial With Nested Case-Control Study
- Record updated
- 13 October 2026