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Procedure

MISHA Knee System for Osteoarthritis

N/A

Recruiting

Led By David Flanigan, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will evaluate the safety and effectiveness of a knee implant system over five years. Subjects will be monitored for adverse events, pain/function scores, satisfaction, and x-rays.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Freedom from device- and procedure-related Subsequent Surgical Interventions

Secondary outcome measures

WOMAC Function

WOMAC Pain

Trial Design

1Treatment groups

Experimental Treatment

Group I: MISHA Knee SystemExperimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

MoximedLead Sponsor

6 Previous Clinical Trials

535 Total Patients Enrolled

5 Trials studying Osteoarthritis

212 Patients Enrolled for Osteoarthritis

David Flanigan, MDPrincipal InvestigatorThe Ohio State University Wexner Medical Center

3 Previous Clinical Trials

171 Total Patients Enrolled

2 Trials studying Osteoarthritis

162 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to register for this medical investigation?

"Eligibility criteria for the clinical trial necessitates that potential participants be aged 25 to 65 and have a diagnosis of osteoarthritis. 120 individuals are needed in total."

Answered by AI

Is the population of this experiment limited to individuals under 25 years old?

"As outlined in the stipulated parameters of this clinical trial, eligible participants must be between 25 and 65 years old."

Answered by AI

Could individuals still join this experiment?

"As is stated on clinicaltrials.gov, this medical study is no longer actively recruiting participants - the trial was initially posted November 6th 2023 and underwent its last update October 31st of the same year. Although there are currently no spots for enrolment in this specific experiment, 708 other studies require volunteer subjects at present."

Answered by AI

Who else is applying?

What site did they apply to?

Oregon Health and Science University

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

Why did patients apply to this trial?

I would like to not have total knee replacement. I am interested in some other type of insert.

PatientReceived 2+ prior treatments

I am an active athlete who is not ready to stop my activities because of knee pain at 42. I have tried cortisone shots and found they only temporary mask the issue/cause more problems later.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

MISHA® Post-Market Clinical Study

2023. "MISHA® Post-Market Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118892.

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