New knee implant aims to ease arthritis pain without full replacement
NCT ID NCT06118892
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This study is testing a device called the MISHA® Knee System to see if it safely relieves pain and improves function in people with medial knee osteoarthritis. About 120 adults aged 25 to 65 who have not gotten relief from other treatments will receive the implant and be followed for 5 years. The main goal is to check how many people avoid additional surgeries related to the device.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2023
- Expected to finish
-
Jul 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
25 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Medial knee osteoarthritis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
4 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Oregon Health and Science University
RECRUITINGPortland, Oregon, 97239, United States
-
Orthopaedics Specialists of NC
RECRUITINGRaleigh, North Carolina, 27614, United States
-
University of Virginia
RECRUITINGCharlottesville, Virginia, 22903, United States
-
Weiss Orthopedics
RECRUITINGSonoma, California, 95476, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Digital tools may help osteoarthritis patients avoid surgery
- Can body weight predict success of knee realignment surgery?
- Can a meditation practice curb Post-Surgery pain and opioid use?
- Can a simple pill speed up knee replacement recovery?
- Could a wearable ultrasound device ease knee arthritis pain without pills?
- Hidden fat in thigh muscles may drive knee arthritis