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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    132
  • sponsor
    Hospital for Special Surgery, New York
Updated on 24 March 2022
anesthesia
postoperative pain
osteoarthritis
total knee replacement
range of motion
stiffness
Accepts healthy volunteers

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.

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 aging US population, nearly 700,000 Americans receive TKAs each year. In spite of surgery, many patients experience persistent pain, stiffness or instability that negatively impacts their quality of life; up to 5% experience TKA failure in the first 10 years.

Presently, IV stress dose steroids is an accepted practice for bilateral knee replacement (BTKR) leading to decreased pain 24 hours after surgery and improved range of motion (ROM) on postoperative day 2 (POD2). These benefits are likely due to suppression of inflammation immediately after surgery. It is not clear if IV stress dose steroids improve ROM at later time points. Moreover, it is not clear if IV hydrocortisone improves clinical outcomes in unilateral TKA, where pain and joint stiffness remain significant challenges weeks after surgery. The investigators hypothesize that IV hydrocortisone will increase ROM at 6 weeks following surgery.

This study will enroll 132 patients that will be followed for up to 2 years. By integrating cell and molecular biology, biomechanics, and imaging technologies (including a CT scan at 1 year), this study is designed to comprehensively examine the long term effects of IV hydrocortisone on joint stiffness, pain, clinically relevant inflammatory states, and the synovium following unilateral TKA. Because subjects with variable ROMs will be enrolled in the study and followed over time, the findings may enable the development of biomarker prediction tools and the targeting of appropriate prevention and management measures for patients at highest risk of joint stiffness and subsequent surgical intervention.

Details
Condition Pain, Arthrofibrosis, Osteoarthritis, Knee
Treatment Hydrocortisone, Dextrose 5% in water (D5W)
Clinical Study IdentifierNCT04082533
SponsorHospital for Special Surgery, New York
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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)
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