| NCT ID | NCT06118892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Moximed |
| Condition | Osteo Arthritis Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-11-03 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-11-03 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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. 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
Contact & Investigator
Dennis Crawford, MD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT06118892 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 65 Years, studying Osteo Arthritis Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06118892 currently recruiting?
Yes, NCT06118892 is actively recruiting participants. Contact the research team at rsweinstein@moximed.com for enrollment information.
Where is the NCT06118892 trial being conducted?
This trial is being conducted at Sonoma, United States, Raleigh, United States, Portland, United States, Charlottesville, United States.
Who is sponsoring the NCT06118892 clinical trial?
NCT06118892 is sponsored by Moximed. The principal investigator is Dennis Crawford, MD at Oregon Health and Science University. The trial plans to enroll 120 participants.