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IV Hydrocortisone for Post-Knee Replacement Recovery

Phase 4
Waitlist Available
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Osteoarthritis (OA) within the affected joint
Elective primary unilateral total knee arthroplasty
Must not have
Non-English speaking
Type II Diabetes on insulin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (preoperative), 6 weeks postop, 1 year postop, 2 years postop
Awards & highlights

Summary

This trial is testing whether or not giving patients hydrocortisone after a total knee replacement can help with stiffness and range of motion.

Who is the study for?
This trial is for adults aged 18 to 83 undergoing elective knee replacement surgery without a history of certain joint treatments or conditions like rheumatic diseases. Participants must not have had steroid injections recently, be on long-term opioids, or have a BMI over 45. They should be able to communicate in English and not have an active infection.
What is being tested?
The study tests if IV hydrocortisone can improve outcomes after knee replacement surgery. Patients are grouped by pre-surgery stiffness and then randomly get either hydrocortisone or placebo postoperatively. Follow-ups occur from the day after surgery up to two years, with blood tests at key intervals.
What are the potential side effects?
Potential side effects of hydrocortisone may include increased blood sugar levels, higher risk of infection, mood swings, elevated blood pressure, insomnia, and possibly weakened bones with long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have osteoarthritis in my joint.
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I am scheduled for a knee replacement surgery on one knee.
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My health is good to moderately impaired.
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I am between 18 and 83 years old.
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I have had spinal or epidural anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English.
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I have Type II Diabetes and am on insulin treatment.
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I am getting a knee replacement without using cement.
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I have had surgery to fix a broken bone with plates or screws.
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I have taken oral steroids in the last 3 months before surgery.
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I have a condition like rheumatoid arthritis or Type I diabetes.
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I have experienced severe nausea or vomiting after surgery or sedation.
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I cannot use certain pain or inflammation medications due to health reasons.
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I currently have an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (preoperative), 6 weeks postop, 1 year postop, 2 years postop
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (preoperative), 6 weeks postop, 1 year postop, 2 years postop for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Range of Motion, Articular
Secondary study objectives
Biomechanical findings
Inflammatory state (via protein, ribonucleic acid (RNA), cellular, and tissue level analyses
Knee injury and Osteoarthritis Outcome Score (KOOS Jr.)
+8 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Non-stiff Intravenous HydrocortisoneActive Control1 Intervention
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.
Group II: Stiffness Intravenous HydrocortisoneActive Control1 Intervention
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.
Group III: Non-stiff Intravenous placeboPlacebo Group1 Intervention
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.
Group IV: Stiffness Intravenous PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
249 Previous Clinical Trials
61,197 Total Patients Enrolled
26 Trials studying Osteoarthritis
4,295 Patients Enrolled for Osteoarthritis

Media Library

Non-stiff Intravenous Hydrocortisone Clinical Trial Eligibility Overview. Trial Name: NCT04082533 — Phase 4
Osteoarthritis Research Study Groups: Non-stiff Intravenous placebo, Non-stiff Intravenous Hydrocortisone, Stiffness Intravenous Placebo, Stiffness Intravenous Hydrocortisone
Osteoarthritis Clinical Trial 2023: Non-stiff Intravenous Hydrocortisone Highlights & Side Effects. Trial Name: NCT04082533 — Phase 4
Non-stiff Intravenous Hydrocortisone 2023 Treatment Timeline for Medical Study. Trial Name: NCT04082533 — Phase 4
~15 spots leftby May 2025
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