MOTION Clinical Trial

Part of paid clinical trials in Davis, California.

Sponsor
Moximed
Study ID
NCT06843980
Status
Recruiting
Apply to this trial

Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
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.
  • Non-Surgical Treatment — OTHER
    The non-surgical arm includes assist devices, physical conditioning, prescription or nonprescription medications, creams, vitamins, or supplements, intra-articular Injections, physical therapy and weight loss.

Study Details

Prospective, multicenter, two-arm, 2:1 randomized controlled trial (RCT) comparing the benefits in subjects with medial knee osteoarthritis who are treated with either the MISHA Knee System or with non-surgical treatment. This is the first randomized head-to-head study comparing outcomes from subjects treated with the MISHA Knee System.

Key Dates

First listed
Feb 25, 2025
Start date
Feb 13, 2025
Status verified
Jul 2026
Primary completion
Apr 30, 2026
Completion
Jun 30, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MISHA Knee System
    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.
  • Active Comparator: Non-Surgical Treatment
    The non-surgical arm includes assist devices, physical conditioning, prescription or nonprescription medications, creams, vitamins, or supplements, intra-articular Injections, physical therapy and weight loss.

Primary Outcome Measure

WOMAC Pain at 6 Months [ Time Frame: 6 Months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
UC Davis Department of Orthopaedic SurgeryDavisCalifornia95816-
Scripps Clinic JeffersonOceansideCalifornia92054
Tianyi Wang, MD
Tianyi Wang, MD (PRINCIPAL_INVESTIGATOR)
Sutter HealthSacramentoCalifornia95816-
Rush University Medical CenterChicagoIllinois60612
Adam Yanke, MD
Adam B Yanke, MD (PRINCIPAL_INVESTIGATOR)
Brian Cole, MD (SUB_INVESTIGATOR)
Genesis Orthopedics & Sports MedicineOak BrookIllinois60523
Hythem Shadid, MD
Hythem Shadid, MD (PRINCIPAL_INVESTIGATOR)
Nolan Horner, MD (SUB_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Matthew Tao, MD
Matthew Tao, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016-
Ohio State Jameson Crane Sports Medicine InstituteColumbusOhio43202
Robert Magnussen, MD
Robert Magnussen, MD (PRINCIPAL_INVESTIGATOR)
David Flanigan, MD (SUB_INVESTIGATOR)
UT Health San AntonioSan AntonioTexas78249
Thomas DeBerardino, MD
Thomas DeBerardino, MD (PRINCIPAL_INVESTIGATOR)
Leah Brown, MD (SUB_INVESTIGATOR)

Find similar trials in Davis, CA

By research site
UC Davis Department of Orthopaedic Surgery· Davis, CAScripps Clinic Jefferson· Oceanside, CASutter Health· Sacramento, CARush University Medical Center· Chicago, ILGenesis Orthopedics & Sports Medicine· Oak Brook, ILUniversity of Nebraska Medical Center· Omaha, NE

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