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Procedure

MISHA Knee System for Osteoarthritis

Columbus, OH

N/A

Recruiting

Research Sponsored by Moximed

Eligibility Criteria Checklist

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

Must have

Failed to find relief in non-surgical treatment modalities

Must not have

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

Ligamentous instability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares the benefits of using the MISHA Knee System versus non-surgical treatment for people with knee osteoarthritis. It is the first study to directly compare outcomes between these two treatments

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Who is the study for?

This trial is for individuals with medial knee osteoarthritis. Specific eligibility details are not provided, but typically participants should meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.Check my eligibility

What is being tested?

The MISHA Randomized Study is testing the effectiveness of the MISHA Knee System compared to non-surgical treatment in managing knee osteoarthritis. It's a prospective, multicenter trial where subjects are randomly assigned in a 2:1 ratio to either intervention.See study design

What are the potential side effects?

Potential side effects are not detailed here, but generally, surgical interventions like the MISHA Knee System can include risks such as infection, pain at the implant site, and possible device failure. Non-surgical treatments may have minimal side effects.

Eligibility Criteria

Inclusion Criteria

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

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Non-surgical treatments have not eased my condition.

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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 damaged.

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I have unstable ligaments.

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I have had a knee infection recently or currently.

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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 inflammation in my joints possibly due to a viral infection.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

WOMAC Pain at 6 Months

Secondary study objectives

WOMAC Function at 6 Months

Awards & Highlights

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: MISHA Knee SystemExperimental Treatment1 Intervention

The MISHA Knee System is an extra-capsular knee implant intended to reduce loads on the medial knee. The implant consists of an absorber located between bases fixed with locking screws to the medial cortices of the distal femur and proximal tibia. The implant shares the load with the medial knee joint and articulating ball-and-sockets allow the device to accommodate the natural motions of the knee.

Group II: Non-Surgical TreatmentActive Control1 Intervention

The non-surgical arm includes assist devices, physical conditioning, prescription or nonprescription medications, creams, vitamins, or supplements, intra-articular Injections, physical therapy and weight loss.

0 / 6Eligibility criteria met