IV Hydrocortisone for Post-Knee Replacement Recovery

Overseen By Kethy M Jules-Elysee, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Oral steroids, Insulin

Disqualifiers: Rheumatic, Autoimmune, Immunodeficiency, Obesity, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: Immediate postoperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if hydrocortisone, a type of steroid, can enhance recovery after knee replacement surgery. Researchers seek to assess its potential to reduce stiffness and improve recovery. Participants will receive either hydrocortisone or a placebo (a harmless substance with no active treatment) post-surgery. The trial suits individuals planning a knee replacement due to osteoarthritis and who do not have severe medical conditions like rheumatoid arthritis or recent steroid use. As a Phase 4 trial, this research explores how an already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have been using oral steroids in the past 3 months or have had intraarticular steroid injections in the last two months, you would not be eligible to participate.

What is the safety track record for hydrocortisone?

Research shows that a low dose of hydrocortisone is safe for patients undergoing knee replacement surgery. Studies have found no increased risk of complications. Hydrocortisone, a type of steroid, has aided recovery in surgeries. One study found that using steroids like hydrocortisone during surgery improved patient mobility and reduced hospital stays. To date, hydrocortisone appears well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using intravenous hydrocortisone for post-knee replacement recovery because it offers a novel approach to managing inflammation and pain. Unlike standard treatments that often rely on oral medications or external therapy, this treatment is administered intravenously, allowing direct and rapid action in reducing inflammation. The active ingredient, hydrocortisone, is a corticosteroid known for its strong anti-inflammatory properties. This method could potentially speed up recovery and improve joint mobility more effectively than current options, which typically include non-steroidal anti-inflammatory drugs (NSAIDs) and physical therapy.

What evidence suggests that hydrocortisone might be an effective treatment for post-knee replacement recovery?

Studies have shown that intravenous hydrocortisone can reduce pain and swelling after knee replacement surgery. In this trial, some participants will receive intravenous hydrocortisone, which research indicates can lead to better early recovery by easing pain and improving knee movement. Other participants will receive a placebo for comparison. Some studies also found that hydrocortisone provides long-lasting pain relief and improves knee bending. Additionally, stress dose steroids like hydrocortisone are commonly used to decrease pain 24 hours after surgery. This makes hydrocortisone a promising option for improving recovery after knee replacement. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am receiving specific nerve blocks and injections for post-surgery pain.

I have osteoarthritis in my joint.

I am scheduled for a knee replacement surgery on one knee.

Exclusion Criteria

Pregnant women

Previous study participants in this study

You have had previous implants or devices placed in the joint being studied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravenous hydrocortisone or placebo at 3 intervals postoperatively

Immediate postoperative period

3 doses every 8 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

In-person visits at 6 weeks, 6 months, 1 year, and 2 years; phone follow-ups on POD 1 and 2

What Are the Treatments Tested in This Trial?

Interventions

• Hydrocortisone

Trial Overview 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.

How Is the Trial Designed?

Group I: Non-stiff Intravenous Hydrocortisone Active Control 1 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 Hydrocortisone Active Control 1 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 placebo Placebo Group 1 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 Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Published Research Related to This Trial

In a study of 117 patients with rheumatoid arthritis, using elastic wrist orthoses for 48 hours after glucocorticoid injections did not significantly reduce the relapse of wrist synovitis compared to normal activity, with 24 relapses in the orthoses group versus 14 in the active group.

The findings suggest that postinjection immobilization may not be beneficial for wrist treatments, indicating that recommendations for postinjection care should be tailored to the specific joint being treated, rather than applying results from knee studies to other joints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled study of postinjection immobilisation after intra-articular glucocorticoid treatment for wrist synovitis. Weitoft, T., Rönnblom, L.[2019]

In a study involving 60 patients undergoing bilateral total knee arthroplasty, the use of a multimodal cocktail injection with corticosteroids did not show significant differences in pain relief, motion range, or swelling compared to injections without corticosteroids.

The findings suggest that multimodal periarticular injections without corticosteroids can effectively manage postoperative pain and swelling, indicating that corticosteroids like betamethasone may not be necessary for optimal outcomes in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Efficacy of Corticosteroids as an Adjuvant for Periarticular Cocktail Injection in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Double-Blind Controlled Trial. Peng, H., Wang, W., Lin, J., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04082533

Intravenous (IV) Hydrocortisone for TKA (Total Knee ... Moreover, it is not clear if IV hydrocortisone improves clinical outcomes in unilateral TKA, where pain and joint stiffness remain significant challenges weeks ...

2. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.1055/s-0038-1636506

A Randomized Clinical Trial - Thieme Connect The visual analog scale (VAS) pain scores were significantly reduced by using two doses of hydrocortisone at the first 12 hours compared with group A (p > 0.05) ...

3. withpower.com withpower.com/trial/phase-4-osteoarthritis-knee-6-2019-6d958

IV Hydrocortisone for Post-Knee Replacement Recovery Research shows that using low doses of hydrocortisone can help reduce pain and inflammation after knee replacement surgery, leading to better early ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11017604/

The efficacy and safety of perioperative glucocorticoid for ... Some studies have indicated that the use of local glucocorticoids results in prolonged pain relief and improved active knee flexion after ...

5. trialx.com trialx.com/clinical-trials/listings/235857/intravenous-iv-hydrocortisone-for-tka-total-knee-arthroplasty/?&geo_lat=40.7928&geo_lng=-73.7767&radius=10&place=Bayside&user_country=United%20States

Intravenous (IV) Hydrocortisone for TKA (Total Knee ... Presently, IV stress dose steroids is an accepted practice for bilateral knee replacement (BTKR) leading to decreased pain 24 hours after ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8681887/

Intra-Articular Corticosteroid Injection After Total Knee ... The results indicated that within six months after IASI into a TKR, 1.9% of TKRs became infected (107 patients) versus 1.1% in the control group ...

7. digitalscholar.lsuhsc.edu digitalscholar.lsuhsc.edu/cgi/viewcontent.cgi?article=1201&context=sommrd

The Effectiveness of Corticosteroid injections in the time ... The major aim of this study is to investigate the relationship between the frequency of. IA corticosteroid injections (number of injections per year) in ...