Osteo Arthritis Knee study: MISHA Knee System
Official title MISHA Post-Market Clinical Study
ClinicalTrials.gov ID: NCT06118892
What this study is testing
- What it's testing
- The study aims to see how safe the MISHA knee implant is and whether it works over five years, looking at infection rates, pain, function, and need for additional surgery.
- Who it's for
- Adults who have knee osteoarthritis and are candidates for the MISHA knee implant.
- What's involved
- Participants will receive the MISHA knee implant and then attend regular clinic visits for exams, X‑rays, and questionnaires about pain, function, activity level, and any complications.
- Time commitment
- The study follows participants for five years with scheduled visits and assessments during that time.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 65
You may be able to join if
- people aged 25 to 65 years at time of index procedure
- Body Mass Index (BMI) of \< 35
- Activity exacerbated knee pain isolated to the medial compartment and not global in nature
- WOMAC pain ≥ 40
- Failed non-operative OA treatment Key
You likely can't join if
- Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
- Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
- Ligamentous instability
- Active or recent knee infection
- Inflammatory joint disease, including sequalae of viral infections
- Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
See the full eligibility criteria
- people aged 25 to 65 years at time of index procedure
- Body Mass Index (BMI) of \< 35
- Activity exacerbated knee pain isolated to the medial compartment and not global in nature
- WOMAC pain ≥ 40
- Failed non-operative OA treatment Key
- Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
- Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
- Ligamentous instability
- Active or recent knee infection
- Inflammatory joint disease, including sequalae of viral infections
- Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
- History of keloid, hypertrophic or contracture scaring
- Propensity for restrictive scar formation or adhesions with prior procedures
The study team makes the final eligibility decision.
Where it is enrolling
- Sonoma, California, United States
- Raleigh, North Carolina, United States
- Portland, Oregon, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sonoma, California, United States; Raleigh, North Carolina, United States; Portland, Oregon, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.