Total Knee Replacement > Methylprednisolone

Medrol Dosepak for Total Knee Replacement

Recruiting in Palo Alto (17 mi)

Overseen By Craig Della Valle, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Rush University Medical Center

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of an oral methylprednisolone taper on acute postoperative pain, function, opioid consumption, nausea, and complications following outpatient total knee arthroplasty (TKA). We hypothesize that administration of an oral methylprednisolone taper starting on postoperative day 1 (POD 1) following TKA will be associated with improved pain and decreased opioid use, nausea, and complications at POD1-7, as compared to similar patients who receive placebo. Additionally, those taking methylprednisolone will report decreased pain and greater objective functional outcomes at 3 and 6 weeks postoperatively as compared to controls.

How is the drug Medrol Dosepak unique for total knee replacement?

Medrol Dosepak, which contains methylprednisolone, is unique because it offers a high-dose oral corticosteroid option that can be used as a substitute for intravenous administration, providing flexibility in managing inflammation and pain after total knee replacement.

^{1 3 5 6 7}

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using chronic corticosteroids or opiates, you cannot participate in the trial.

What data supports the effectiveness of the drug Medrol Dosepak for total knee replacement?

Methylprednisolone, a component of Medrol Dosepak, has been used to relieve pain in conditions like diskogenic back pain and rheumatoid arthritis, suggesting it may help with inflammation and pain management after knee replacement surgery.

^{1 2 3 6 7}

Is Medrol Dosepak (Methylprednisolone) generally safe for humans?

Methylprednisolone, used in various forms like Medrol Dosepak, has been associated with complications when accidentally injected into the eye, causing retinal damage. However, when used correctly, it is generally considered safe, as studies show it is rapidly cleared from the body and does not cause significant tissue changes in controlled settings.

^{1 3 4 6 7}

Eligibility Criteria

This trial is for adults over 18 undergoing their first total knee replacement due to osteoarthritis. Participants must be willing to be randomly assigned a treatment and able to take oral medication. It's not for those with certain chronic diseases, immune system issues, or infections; pregnant women; or anyone unable to consent.

Inclusion Criteria

I am having a knee replacement due to osteoarthritis.

I am 18 years old or older.

Exclusion Criteria

My immune system is weak due to a condition or medication.

I am unable to give my consent.

I cannot take medications by mouth.

I am having or have had a second knee replacement surgery.

I am 18 years old or younger.

I do not have a fungal or other infection right now.

I have a history of conditions like hypothyroidism, heart failure, or myasthenia gravis.

I regularly use corticosteroids or opiates.

My primary diagnosis is not osteoarthritis but could be avascular necrosis, a fracture, or post-traumatic arthritis.

I am currently pregnant.

I might have an infection around my artificial joint.

My health is severely limited by my illness.

I have an active stomach or intestinal ulcer.

Participant Groups

The study tests if an oral steroid called methylprednisolone can reduce pain, improve function, lessen opioid use and nausea after knee surgery compared to a placebo. The effects are measured from the day after surgery up to six weeks postoperatively.

Group I: Methylprednisolone taper Experimental Treatment 1 Intervention

Methylprednisolone taper - 21 x 4mg tablets beginning on POD 1

Group II: Placebo taper Placebo Group 1 Intervention

2.Placebo taper - 21 sugar tablets beginning on POD 1 with standard management

Methylprednisolone is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Medrol for:

• Allergic reactions
• Blood disorders
• Cancer
• Eye diseases
• Immune system disorders
• Inflammatory diseases
• Respiratory diseases
• Skin diseases

🇪🇺 Approved in European Union as Depo-Medrol for:

• Allergic reactions
• Blood disorders
• Cancer
• Eye diseases
• Immune system disorders
• Inflammatory diseases
• Respiratory diseases
• Skin diseases

🇨🇦 Approved in Canada as Solu-Medrol for:

• Allergic reactions
• Blood disorders
• Cancer
• Eye diseases
• Immune system disorders
• Inflammatory diseases
• Respiratory diseases
• Skin diseases

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Rush Oak Brook Outpatient Center Oak Brook, IL

Who is running the clinical trial?

Rush University Medical Center Lead Sponsor

References

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

Management of diskogenic pain using epidural and intrathecal steroids. [2019] The use of methylprednisolone acetate (Depo-Medrol) injected by the epidural or intrathecal route for the relief of diskogenic back pain with or without radiculopathy is an adjunct to conservative management useful when conservative measures fail and surgical treatment is under consideration. This is especially true when symptoms have been present for only a few months. Corticosteroids injected in the same manner seem to have little effect on patients with symptoms persisting for periods longer than 3 months or in patients treated previously by surgical methods.

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

Osmic acid in rheumatoid synovitis. A controlled study. [2019] In 24 adult RA patients with knee joint synovitis and bilateral hydrops, the worse joint clinically was treated with osmic acid and 50 mg of hydrocortisone acetate, while the better joint clinically was treated with 40 mg of methylprednisolone acetate (Depot Medrol). After 6 months, hydrops was palpable in 8 joints treated with osmic acid and in 15 joints treated with corticosteroid only. Pain relief was more marked in joints treated with osmic acid.

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

The systemic and local effects of an intramedullary injection of methylprednisolone acetate in growing rabbits. [2019] Intramedullary injection of methylprednisolone acetate (Depo-Medrol) is successful in the treatment of children with unicameral cysts, but its mechanism of action remains obscure. Using a rabbit model, methylprednisolone was injected into the intramedullary canal of the left proximal tibia. Normal saline was injected into the right proximal tibia as a control. Venous blood samples following injection revealed that corticosteroid was rapidly cleared from bone. Serum methylprednisolone levels rose rapidly, giving a dose-response curve similar to that after an intramuscular injection in humans. Rabbits were killed and analyzed histologically for local changes. There was no fibroblastic proliferation, neovascularization, or other histologic change secondary to injection.

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

Iatrogenic intraocular injection of depot corticosteroid and its surgical removal using the pars plana approach. [2019] A four-year-old girl, while undergoing a repeat excisional biopsy for a progressive orbital hemangioma, sustained an accidental intraocular injection of methylprednisolone acetate (Depo-Medrol) resulting in a mass of intravitreal and subretinal depot material as well as a retinal tear, retinal detachment, and rapid cataract formation. Pars plana lensectomy, vitrectomy, xenon arc endophotocoagulation and air fluid-gas exchange techniques were used to restore the ocular tissues for visual functions in the affected eye and to save the globe from the devastating toxic effects of the vehicles in the depot corticosteroid preparation.

5. Germany pubmed.ncbi.nlm.nih.gov

Absolute bioavailability of a new high dose methylprednisolone tablet formulation. [2013] This was a single-blind, single-dose, randomized crossover study to determine the absolute bioavailability of Medrol, a new high dose (100 mg) methylprednisolone tablet product, by comparing it with 100 mg methylprednisolone from an intravenous formulation, Solu-Medrol. Fourteen healthy, non-smoking, Caucasian male volunteers took part. On treatment days volunteers remained recumbent for 4 hours after drug administration, with food and fluid intake standardized over this period. Serial blood samples were drawn over a 14-hour period after drug administration. Plasma methylprednisolone concentrations were determined by high performance liquid chromatography. The geometric means of AUCi.v. and AUCtablet were 4,049 and 3,334 ng.h/ml, respectively. The absolute bioavailability of the tablet product was 82%, which is in agreement with published data for other oral dosage forms of methylprednisolone. Volunteers displayed the expected rise in peripheral blood neutrophil count, but no other clinically relevant changes in hematology or clinical chemistry were observed. No adverse drug reactions were recorded. It is concluded that the tablet product can be used as a substitute for parenteral methylprednisolone in situations requiring high-dose therapy.

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

Survey of orthopaedic and sports medicine physicians regarding use of medrol dosepak for sports injuries. [2018] To study the use of a methylprednisolone taper (Medrol Dosepak; Pfizer, New York, NY) short-term oral corticosteroid treatment modality by sports medicine physicians; included is discussion on indications, perceived efficacy, and complications.

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

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. [2014] Methylprednisolone acetate (Depo-Medrol, Pfizer, New York) is a depot corticosteroid that is commonly injected periorbitally to treat various ophthalmologic conditions. Accidental intravitreal injections secondary to globe perforations have resulted in rapid retinal toxicity. To their knowledge, the authors report the first case of inadvertent intravitreal methylprednisolone acetate injection during pars plana vitrectomy.