What is the mechanism of action of this treatment?

Common treatments for osteoarthritis (OA) work through various mechanisms to alleviate pain and improve joint function. NSAIDs reduce inflammation and pain by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which are involved in the inflammatory process. Duloxetine, an antidepressant, helps manage chronic pain by increasing serotonin and norepinephrine levels in the brain, which modulate pain perception. Intraarticular glucocorticoid injections provide short-term pain relief by reducing local inflammation within the joint. Surgical interventions like total joint arthroplasty replace the damaged joint with a prosthesis, offering significant pain relief and improved function for severe cases. The MISHA Knee System, an orthopedic implant, aims to stabilize the knee joint and reduce pain, potentially delaying the need for more invasive surgeries. Understanding these mechanisms helps OA patients and their doctors choose the most appropriate treatment based on the severity of symptoms and individual patient needs.

What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, particularly those involving surgical interventions like the MISHA Knee System, include total knee replacement and arthroscopic procedures. These surgeries can lead to complications such as infection, thrombotic events, and the need for revision surgery. Non-surgical treatments like NSAIDs are associated with gastrointestinal, cardiovascular, and renal side effects. Intraarticular glucocorticoid injections, while providing short-term pain relief, can lead to joint infection and cartilage damage with repeated use. Other pharmacological treatments like duloxetine may cause nausea, dry mouth, and fatigue. Overall, each treatment option carries its own risk profile, and decisions should be made in consultation with a healthcare provider.

What prior FDA approvals exist?

The MISHA Knee System is an orthopedic implant designed for knee joint stabilization and pain relief. Similar FDA-approved treatments for osteoarthritis include various types of knee replacement surgeries and implants, such as total knee arthroplasty (TKA) and partial knee arthroplasty (PKA). These surgical interventions aim to relieve pain and improve joint function by replacing damaged joint surfaces with prosthetic components. Additionally, other FDA-approved treatments for osteoarthritis include non-surgical options like NSAIDs, intra-articular corticosteroids, and hyaluronic acid injections, which focus on pain management and improving joint mobility.

What other types of research exist?

Promising alternatives to the MISHA Knee System for osteoarthritis patients include: 1) The new articulated distraction arthroplasty device, which has shown significant improvements in knee scores, range of motion, and pain relief. 2) The iForma ConforMIS Interpositional knee device, which is less invasive and preserves future treatment options. 3) The Latella Knee Implant, which has shown encouraging early clinical results for medial knee osteoarthritis.

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Procedure

MISHA Knee System for Osteoarthritis

N/A

Recruiting

Led By Dennis Crawford, MD

Research Sponsored by Moximed

Eligibility Criteria Checklist

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

Must have

Subjects aged 25 to 65 years at time of index procedure

WOMAC pain ≥ 40

Must not have

Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)

Propensity for restrictive scar formation or adhesions with prior procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new knee implant called the MISHA Knee System. It aims to help people who need knee implants by improving their knee function and reducing pain. The study will follow patients over several years to see how well the implant works and if it is safe.

Who is the study for?

This trial is for people aged 25-65 with osteoarthritis, experiencing pain mainly in the knee's medial compartment. They must have a BMI of less than 35 and have tried non-surgical treatments without success. It's not for those with poor bone quality, metal allergies, large knee growths that could affect the device, unstable ligaments, recent infections or inflammatory diseases.

What is being tested?

The MISHA Knee System is being tested to see if it's safe and effective for treating knee osteoarthritis. The study will track patients' pain levels, satisfaction, range of motion and activity over five years post-implantation. It aims to determine how many participants remain free from serious side effects related to the device or procedure after five years.

What are the potential side effects?

Potential side effects include procedural complications like infection or adverse reactions specific to the implant material (such as metal sensitivity), issues arising from improper placement or function of the device leading to additional surgeries including possible conversion to full arthroplasty.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 25 and 65 years old.

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My knee or hip pain is severe, scoring 40 or more.

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My non-surgical treatment for osteoarthritis didn't work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My bones are weak or easily break.

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I tend to develop thick scars or internal scar tissue after surgery.

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I have large bone spurs or significant knee cartilage issues that could affect a device's placement or function.

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I have unstable ligaments.

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I have had a knee infection recently or it's still active.

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I have joint inflammation due to disease or past infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

WOMAC Function

WOMAC Pain

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: MISHA Knee SystemExperimental Treatment1 Intervention

0 / 9Eligibility criteria met

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 osteoarthritis (OA) work through various mechanisms to alleviate pain and improve joint function. NSAIDs reduce inflammation and pain by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which are involved in the inflammatory process. Duloxetine, an antidepressant, helps manage chronic pain by increasing serotonin and norepinephrine levels in the brain, which modulate pain perception. Intraarticular glucocorticoid injections provide short-term pain relief by reducing local inflammation within the joint. Surgical interventions like total joint arthroplasty replace the damaged joint with a prosthesis, offering significant pain relief and improved function for severe cases. The MISHA Knee System, an orthopedic implant, aims to stabilize the knee joint and reduce pain, potentially delaying the need for more invasive surgeries. Understanding these mechanisms helps OA patients and their doctors choose the most appropriate treatment based on the severity of symptoms and individual patient needs.

Combined Treatment With Chondroitin Sulfate and Glucosamine Sulfate Shows No Superiority Over Placebo for Reduction of Joint Pain and Functional Impairment in Patients With Knee Osteoarthritis: A Six-Month Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.Comparative effectiveness of pharmacologic interventions for knee osteoarthritis: a systematic review and network meta-analysis.