Methylprednisolone for Knee Arthritis

Recruiting at 1 trial location

Overseen By Johannes F Plate, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: F. Johannes Plate

Must not be taking: Chronic steroids, Opioids

Disqualifiers: Diabetes, Chronic pain, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 2

Duration: 6 days

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic steroid treatments or opioids for pain, you would not be eligible to participate.

What data supports the effectiveness of the drug Methylprednisolone for knee arthritis?

Methylprednisolone has been shown to be effective in managing pain and inflammation in conditions like diskogenic back pain and rheumatic diseases, suggesting it may help with knee arthritis as well. Additionally, the drug is well-absorbed in the body, making it a reliable option for high-dose therapy. ^{1 2 3 4 5}

Is methylprednisolone generally safe for humans?

Methylprednisolone, used in various forms like Medrol and Solu-Medrol, has been studied for safety in humans. In a study with healthy volunteers, no adverse reactions were recorded, and it was well-tolerated. However, accidental injection into the eye can cause serious damage, highlighting the importance of proper administration. ^{1 2 4 5 6}

What makes the drug methylprednisolone unique for treating knee arthritis?

Methylprednisolone is a corticosteroid that can be administered in various ways, such as intramuscularly or as a depot injection, which allows for a slow release over time. This can provide longer-lasting relief compared to other treatments that may require more frequent dosing. ^{2 3 4 6 7}

What is the purpose of this trial?

Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. This study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. A taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.

Research Team

Johannes F Plate

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals with knee arthritis who have undergone total knee arthroplasty. Participants should be interested in improving postoperative pain and range of motion. Specific inclusion and exclusion criteria are not provided, but typically would involve age, overall health status, and absence of conditions that could interfere with the study.

Inclusion Criteria

Access to computer or smartphone for completion of REDCap surveys

I am recommended to have a total knee replacement.

Exclusion Criteria

I am on long-term steroid medication.

Immunosuppressed patients

Known diabetic patients with an HgbA1c >6.5 preoperatively

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intraoperative intravenous dexamethasone and a 6-day post-operative methylprednisolone taper

6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including knee function, pain, and wound healing

3 months

2-week, 6-week, and 3-month postoperative visits

Treatment Details

Interventions

• Methylprednisolone

Trial Overview The study tests if a tapering dose of methylprednisolone after surgery can improve functional outcomes compared to just using dexamethasone during surgery. A taper involves starting with a high dose then gradually reducing it over several days.

Participant Groups

Group I: Intraoperative and Post-operative steroid Experimental Treatment 2 Interventions

Patients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper

Group II: Intraoperative Steroid Active Control 1 Intervention

Patients randomized to this group will only receive intraoperative intravenous dexamethasone

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

Who Is Running the Clinical Trial?

F. Johannes Plate

Lead Sponsor

Trials

1

Recruited

100+

Findings from Research

Inadvertent injection of methylprednisolone acetate into the eye during vitrectomy can lead to severe retinal toxicity, resulting in significant vision loss and complications such as retinal necrosis and optic nerve damage.

This case highlights the critical need for careful identification of medications during eye surgeries to prevent serious adverse effects associated with incorrect injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. Yonekawa, Y., Sun, G., D'Amico, DJ., et al.[2014]

Intramedullary injection of methylprednisolone acetate (Depo-Medrol) effectively treats unicameral cysts in children, as demonstrated in a rabbit model where the drug was injected into the tibia.

The study found that while serum levels of methylprednisolone rose quickly, indicating systemic absorption, there were no significant local histological changes such as fibroblastic proliferation or neovascularization, suggesting that the mechanism of action may not involve direct tissue alteration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The systemic and local effects of an intramedullary injection of methylprednisolone acetate in growing rabbits. Colville, MR., Aronson, DD., Prcevski, P., et al.[2019]

Methylprednisolone acetate (Depo-Medrol) injections via epidural or intrathecal routes can effectively relieve diskogenic back pain and radiculopathy when conservative treatments have failed, particularly if symptoms have lasted less than three months.

Corticosteroid injections are less effective for patients with chronic symptoms lasting over three months or those who have previously undergone surgery, suggesting a limited window for optimal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of diskogenic pain using epidural and intrathecal steroids. Brown, FW.[2019]

The study found that the new high-dose (100 mg) methylprednisolone tablet has an absolute bioavailability of 82%, indicating it is effectively absorbed in the body when taken orally.

No adverse drug reactions were reported, and the tablet can safely substitute for intravenous methylprednisolone in high-dose therapy, as it produced expected changes in blood neutrophil counts without significant side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absolute bioavailability of a new high dose methylprednisolone tablet formulation. Groenewoud, G., Hundt, HK., Luus, HG., et al.[2013]

In a study of 901 patients with relapsing-remitting multiple sclerosis, methylprednisolone (MP) pulse therapy was administered with a mean frequency of 4 times, showing that the majority of patients received treatment multiple times, indicating its common use in managing acute exacerbations.

The study found that female patients were approximately 3.7 times more likely to seek MP pulse therapy compared to male patients, suggesting a gender difference in treatment-seeking behavior for MS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary study related the incidence of methylprednisolone pulse therapy in patients visited multiple sclerosis clinic located at the isfahan kashani hospital. Tolou-Ghamari, Z., Shaygannejad, V., Ashtari, F.[2022]

A case of conjunctival necrosis occurred in an 82-year-old patient after an inadvertent subconjunctival injection of methylprednisolone following cataract surgery, highlighting a serious complication associated with this medication.

Methylprednisolone is not approved for use in the eye, and this incident underscores the risks of using unapproved medications in ophthalmic procedures, emphasizing the need for caution and adherence to approved treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conjunctival Necrosis due to Subconjunctival Methylprednisolone (Depo-Medrol™) Acetate Injection. van Zyl, LM., Hill, JJ.[2021]

References

1. Ukraine pubmed.ncbi.nlm.nih.gov

[A comparative evaluation of the efficacy of peroral and intravenous pulse therapy with methylprednisolone in rheumatic diseases]. [2016]

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

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. [2014]

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

The systemic and local effects of an intramedullary injection of methylprednisolone acetate in growing rabbits. [2019]

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

Management of diskogenic pain using epidural and intrathecal steroids. [2019]

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

Absolute bioavailability of a new high dose methylprednisolone tablet formulation. [2013]

6. Iran pubmed.ncbi.nlm.nih.gov

Preliminary study related the incidence of methylprednisolone pulse therapy in patients visited multiple sclerosis clinic located at the isfahan kashani hospital. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Conjunctival Necrosis due to Subconjunctival Methylprednisolone (Depo-Medrol™) Acetate Injection. [2021]