What side effects are associated with this type of intervention?

Common treatments for knee arthritis, such as glucocorticoids and NSAIDs, have several known side effects. Glucocorticoids like the Medrol Dose Pak can increase the risk of infections, cause gastrointestinal issues, and potentially lead to hepatotoxicity. NSAIDs, while effective for pain relief, can cause gastrointestinal side effects such as gastritis, increase cardiovascular risks, and lead to renal issues. Both treatments necessitate careful monitoring to ensure a balance between efficacy and safety.

What prior FDA approvals exist?

The FDA has approved various treatments for knee arthritis, including glucocorticoids like methylprednisolone and triamcinolone, which are used for their anti-inflammatory properties to reduce pain and swelling. These drugs work by blocking the inflammatory process and are often administered via intra-articular injections for localized relief. Additionally, nonsteroidal anti-inflammatory drugs (NSAIDs) and other disease-modifying antirheumatic drugs (DMARDs) have been approved for managing symptoms and slowing disease progression in knee arthritis.

What other types of research exist?

Promising novel alternatives to Medrol Dose Pak for knee arthritis patients include intra-articular injections of TNF inhibitors such as etanercept and infliximab, which have shown efficacy in reducing joint pain and inflammation. Additionally, IL-17 inhibitors like secukinumab and ixekizumab, as well as JAK inhibitors such as tofacitinib, are emerging as effective treatments for inflammatory arthritis, including knee arthritis.

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Methylprednisolone for Knee Arthritis

Phase 4

Recruiting

Led By Ajay Premkumar, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether a short-term course of medication can reduce pain, nausea, and the need for opioids in patients after knee replacement surgery. The study involves patients who are having knee replacement surgery and aims to see if this medication can improve their recovery by reducing inflammation. Certain medications have been shown to improve recovery and reduce nausea in various surgical settings.

Who is the study for?

This trial is for patients aged 18 to 95 who are undergoing their first total knee replacement due to severe knee arthritis. It's not suitable for those with other conditions that might affect the surgery or recovery.

What is being tested?

The study tests if a short-term steroid medication called Medrol Dose Pak can reduce pain, nausea, and opioid use after knee replacement surgery compared to standard post-surgery care.

What are the potential side effects?

Possible side effects of Methylprednisolone include increased blood sugar levels, mood swings, increased risk of infection, high blood pressure, and stomach ulcers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Nausea score during Follow Up Period

Changes in Pain Score during Follow up period

Secondary study objectives

Changes in post operative knee function utilizing Knee injury and Osteoarthritis Outcome Score (KOOS)

Changes in the postoperative range of motion following total knee arthroplasty (TKA)

Compare patient satisfaction with acute postoperative pain control

+1 more

Awards & Highlights

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Group: Medrol DoseExperimental Treatment1 Intervention

The perioperative Medrol dose treatment will consist of a course that lasts six days, with 24 milligrams administered on the first day, 20 milligrams on the second day, 60 milligrams on the third day, 12 milligrams on the fourth day, 8 milligrams on the fifth day, and 4 milligrams on the sixth day. Patients will then be followed up at the clinic for six weeks following their procedure to allow for clinical evaluation and to measure outcome variables.

Group II: Control Group: Standard of CareActive Control1 Intervention

Patients in this group will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylprednisolone

2015

Completed Phase 4

~2280

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for knee arthritis include glucocorticoids, NSAIDs, and biologics. Glucocorticoids, like the Medrol Dose Pak, reduce inflammation by blocking the inflammatory process, which helps decrease pain and swelling. NSAIDs work by inhibiting prostaglandin synthesis, thereby reducing inflammation and pain. Biologics target specific components of the immune system to reduce inflammation. Understanding these mechanisms is important for knee arthritis patients as it helps in selecting the most effective treatment based on the specific inflammatory pathways involved in their condition.

[Methods and statistics of multicentral double-blind "cross-over" examination of naproxen compared to indomethacin].A comparison of synovial fluid concentrations of non-steroidal anti-inflammatory drugs with their in vitro activity.[Pharmacological studies of N-(2-mercapto-2-methylpropanoyl)-L-cysteine (SA96). V. Effects of SA96 in combination with indomethacin or prednisolone on adjuvant arthritis in rats].