MISHA Post-Market Clinical Study

Part of paid clinical trials in Sonoma, California.

Sponsor
Moximed
Study ID
NCT06118892
Status
Recruiting
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Conditions

  • Osteo Arthritis Knee

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MISHA Knee System — DEVICE
    The MISHA Knee System is an extra-capsular knee implant intended to reduce loads on the medial knee. The implant consists of an absorber located between bases fixed with locking screws to the medial cortices of the distal femur and proximal tibia. The implant shares the load with the medial knee joint and articulating ball-and-sockets allow the device to accommodate the natural motions of the knee.

Study Details

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.

Key Dates

Start date
Nov 3, 2023
Status verified
Mar 2026
Primary completion
Jun 30, 2030
Completion
Jul 30, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MISHA Knee System

Primary Outcome Measure

Freedom from device- and procedure-related Subsequent Surgical Interventions [ Time Frame: 5 years post-implantation ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Weiss OrthopedicsSonomaCalifornia95476
Noah Weiss
Noah Weiss, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Dennis Crawford, MD
Dennis Crawford, MD (PRINCIPAL_INVESTIGATOR)
Samantha Raphael, PA (SUB_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
David Diduch, MD
David Diduch, MD (PRINCIPAL_INVESTIGATOR)
Frank Gwathmey, MD (SUB_INVESTIGATOR)

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By research site
Weiss Orthopedics· Sonoma, CAOregon Health and Science University· Portland, ORUniversity of Virginia· Charlottesville, VA

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