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IV Hydrocortisone for Post-Knee Replacement Recovery
Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (preoperative), 6 weeks postop, 1 year postop, 2 years postop
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Range of Motion, Articular
Secondary outcome measures
Biomechanical findings
Inflammatory state (via protein, ribonucleic acid (RNA), cellular, and tissue level analyses
Knee injury and Osteoarthritis Outcome Score (KOOS Jr.)
+8 moreTrial 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
243 Previous Clinical Trials
59,232 Total Patients Enrolled
26 Trials studying Osteoarthritis
4,295 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had previous implants or devices placed in the joint being studied.I do not speak English.I am receiving specific nerve blocks and injections for post-surgery pain.I have not had steroid injections in the joint needing surgery in the last 2 months.I have Type II Diabetes and am on insulin treatment.I have osteoarthritis in my joint.I am getting a knee replacement without using cement.I am scheduled for a knee replacement surgery on one knee.I have used opioids daily for more than 6 weeks or used opioids not prescribed to me in the last year.My health is good to moderately impaired.I am between 18 and 83 years old.I have had surgery to fix a broken bone with plates or screws.I have taken oral steroids in the last 3 months before surgery.I have a condition like rheumatoid arthritis or Type I diabetes.I have experienced severe nausea or vomiting after surgery or sedation.I have had spinal or epidural anesthesia.I cannot use certain pain or inflammation medications due to health reasons.I currently have an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Non-stiff Intravenous placebo
- Group 2: Non-stiff Intravenous Hydrocortisone
- Group 3: Stiffness Intravenous Placebo
- Group 4: Stiffness Intravenous Hydrocortisone
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I possibly qualify to partake in this research project?
"To meet the eligibility requirements of this clinical trial, patients must experience pain and be between 18 and 83 years old. Presently, 132 participants are being sourced for participation in this study."
Answered by AI
What clinical applications does Stiffness Intravenous Hydrocortisone have?
"Stiffness Intravenous Hydrocortisone can be an effective treatment for ulcerative colitis, certain types of cancer, and varicella-zoster virus acute retinal necrosis."
Answered by AI
Is there any potential for harm related to Stiffness Intravenous Hydrocortisone usage?
"Our internal assessment has rated the safety of intravenous hydrocortisone a 3, as this is a Phase 4 trial and the medication has already been approved."
Answered by AI
Are geriatric patients excluded from this experiment?
"This research is looking for participants that are at least 18 years old, but below the age of 83."
Answered by AI
Is this clinical trial accepting participants at the present moment?
"Affirmative. The clinical trial is actively seeking out suitable candidates, as indicated by the information on clinicaltrials.gov. It was initially posted in July of 2019 and last updated in September 2022, with a goal to recruit 132 patients from 1 site."
Answered by AI
Have any prior studies been conducted with Stiffness Intravenous Hydrocortisone?
"Presently, the landscape of Stiffness Intravenous Hydrocortisone clinical trials features 60 live studies with 20 in Phase 3. Most are found in New york City, but 3054 other locations feature research related to this medication."
Answered by AI
How many people have enrolled in this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this research study is recruiting individuals at the moment; it was initially posted on July 24th 2019 and updated most recently in September 20th 2022. 132 people need to be recruited from one clinic for full participation."
Answered by AI
Who else is applying?
What site did they apply to?
Hospital for Special Surgery
What portion of applicants met pre-screening criteria?
Met criteria
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