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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

Drug Has Already Been Approved

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

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

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 14Eligibility criteria met