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

NCT04082533 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 2018-0660
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pain; Arthrofibrosis; Osteoarthritis, Knee

Keywords

total knee replacement; hydrocortisone

Outcome Measures

Primary Outcomes (1)

• Postoperative Range of Motion (ROM)

  The primary outcome is range of motion at patients' 6 week (±2 weeks) postoperative surgeon appointment.

  6 weeks postoperative (±2 weeks)

Secondary Outcomes (11)

• Postoperative Stiffness

  6 weeks postoperative (±2 weeks)

• Numeric Rating Scale (NRS)

  baseline (preoperative), postoperative day (POD) 1, POD2, 6 weeks postop, 1 year postop, 2 years postop

• PainDETECT Neuropathic Pain Score

  baseline (preoperative), 6 weeks postop, 1 year postop, 2 years postop

• Opioid consumption

  pre-surgical screening (PSS and holding area), day of surgery (DOS), POD1, POD2 at 6 weeks, 6 months 1 year and 2 years postoperatively,

• Knee injury and Osteoarthritis Outcome Score (KOOS Jr.)

  Preoperative, 6 weeks, 6 months, 1 year, 2 years postoperative

Study Arms (4)

Stiffness Intravenous Hydrocortisone

ACTIVE COMPARATOR

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.

Drug: Hydrocortisone

Stiffness Intravenous Placebo

PLACEBO COMPARATOR

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.

Drug: Dextrose 5% in water (D5W)

Non-stiff Intravenous Hydrocortisone

ACTIVE COMPARATOR

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.

Drug: Hydrocortisone

Non-stiff Intravenous placebo

PLACEBO COMPARATOR

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.

Drug: Dextrose 5% in water (D5W)

Interventions

Hydrocortisone DRUG

Patients will be receiving 100 mg intravenous hydrocortisone every 8 hours, starting in the holding area roughly 2 hours prior to first incision.

Non-stiff Intravenous Hydrocortisone; Stiffness Intravenous Hydrocortisone

Dextrose 5% in water (D5W) DRUG

Patients will be receiving a matched volume of D5W every 8 hours, starting in the holding area roughly 2 hours prior to first incision.

Also known as: Placebo

Non-stiff Intravenous placebo; Stiffness Intravenous Placebo

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pain; Osteoarthritis, Knee

Interventions

Hydrocortisone; Glucose; Water

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: September 9, 2019
• Study Start: July 24, 2019
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Supporting information will be made available when results are posted.
• Access Criteria: Proposals should be directed to the Principal Investigator and may be submitted up to 36 months after article publication.

Locations

US (1)