No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
25 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Moximed · Industry
Who this trial is looking for
This trial is looking for adults with knee osteoarthritis who are experiencing pain and have not found relief from other treatments. Participants will be monitored for up to five years after receiving the MISHA Knee System.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 25 and 65 years old.
I have a BMI of less than 35.
I have knee pain that is mainly on the inner side of my knee.
My WOMAC pain score is 40 or higher.
I have tried other treatments for osteoarthritis that did not work.
You may not be able to join if
I have large bone growths or significant damage to my knee.
I have weak bone quality.
I have instability in my knee ligaments.
I currently have an infection in my knee.
I have inflammatory joint disease or recent viral joint issues.
I am allergic to cobalt, chromium, nickel, or other metals.
I have a history of keloids or excessive scar tissue.
I have a tendency to form restrictive scars or adhesions from past surgeries.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Prospective evaluation of the safety and effectiveness of the MISHA Knee System.
The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions, BMI levels, range of motion, UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post-procedur…
Prospective evaluation of the safety and effectiveness of the MISHA Knee System.
The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions, BMI levels, range of motion, UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post-procedure.
The primary analysis of this study is freedom from device- and procedure-related SSIs at five (5) years post-implantation.
This study will also assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years.
Study subjects will be followed over a five-year post-implant period.
Trial Locations
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City
State
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Status
Eligibility Criteria
Key Inclusion Criteria:
1. Subjects aged 25 to 65 years at time of index procedure
2. Body Mass Index (BMI) of \< 35
3. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
4. WOMAC pain ≥ 40
5. Failed non-operative OA treatment
Key Exclusion Criteria:
1. Lar…
Key Inclusion Criteria:
1. Subjects aged 25 to 65 years at time of index procedure
2. Body Mass Index (BMI) of \< 35
3. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
4. WOMAC pain ≥ 40
5. Failed non-operative OA treatment
Key Exclusion Criteria:
1. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
2. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
3. Ligamentous instability
4. Active or recent knee infection
5. Inflammatory joint disease, including sequalae of viral infections
6. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
7. History of keloid, hypertrophic or contracture scaring
8. Propensity for restrictive scar formation or adhesions with prior procedures
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