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

132 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug 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 rehabilitation and shorter hospital stays. Patients receiving multiple doses of hydrocortisone experienced better pain management, fewer side effects like nausea, and improved knee function compared to those who did not receive the drug. ^{1 2 3 4 5}

Is IV hydrocortisone safe for post-knee replacement recovery?

Research shows that low-dose hydrocortisone can be safely used in patients undergoing knee replacement surgery without increasing the risk of complications. In a study, patients who received hydrocortisone did not experience more infections or adverse events compared to those who received a placebo. ^{1 3 6 7 8}

How does IV hydrocortisone differ from other treatments for post-knee replacement recovery?

IV hydrocortisone is unique because it is administered intravenously (directly into the bloodstream), which can provide rapid relief from inflammation and pain compared to other treatments that might be applied locally or taken orally. This method of delivery can be particularly beneficial in managing postoperative recovery after knee replacement surgery. ^{1 6 9 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The role of perioperative intravenous low-dose dexamethasone in rapid recovery after total knee arthroplasty: a meta-analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Perioperative systemic steroid for rapid recovery in total knee and hip arthroplasty: a systematic review and meta-analysis of randomized trials. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Low-Dose Perioperative Corticosteroids Can Be Administered Without Additional Morbidity in Patients Undergoing Bilateral Total Knee Replacement: A Retrospective Follow-up Study of a Randomized Controlled Trial. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Multiple Low Doses of Intravenous Corticosteroids to Improve Early Rehabilitation in Total Knee Arthroplasty: A Randomized Clinical Trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Pain Relief After Total Knee Arthroplasty with Intravenous and Periarticular Corticosteroid: A Randomized Controlled Trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Rational substitution therapy for steroid-treated patients. [2019]

7. England pubmed.ncbi.nlm.nih.gov

How hydrocortisone substitution influences the quality of life and the bone metabolism of patients with secondary hypocortisolism. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Cushing's syndrome with subsequent tertiary adrenocortical insufficiency after simultaneous multiple intra-articular local glucocorticoid treatment : Keep an eye on hormone deficiency conditions requiring treatment after multiple administrations of local steroids]. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Combination Effect of High-Dose Preoperative and Periarticular Steroid Injection in Total Knee Arthroplasty. A Randomized Controlled Study. [2021]

10. United States 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. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Randomised controlled study of postinjection immobilisation after intra-articular glucocorticoid treatment for wrist synovitis. [2019]