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

Start date
Feb 13, 2025
Status verified
Jun 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 (8)

FacilityCityStateZIPSite coordinators
UC Davis Department of Orthopaedic SurgeryDavisCalifornia95816-
Scripps Clinic JeffersonOceansideCalifornia92054
Boyka Petrov
Tianyi Wang, MD (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Carla Edwards
Adam B Yanke, MD (PRINCIPAL_INVESTIGATOR)
Brian Cole, MD (SUB_INVESTIGATOR)
Genesis Orthopedics & Sports MedicineOak BrookIllinois60523
Noor Alyousef
[email protected]
Hythem Shadid, MD (PRINCIPAL_INVESTIGATOR)
Nolan Horner, MD (SUB_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Dana Schwarz
[email protected]
Matthew Tao, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Kobe Rodney
Alexander Golant, MD (PRINCIPAL_INVESTIGATOR)
Guillem Gonzalez-Lomas, MD (SUB_INVESTIGATOR)
Laith Jazrawi, MD (SUB_INVESTIGATOR)
Ohio State Jameson Crane Sports Medicine InstituteColumbusOhio43202
Jenna DeFranco
[email protected]
Robert Magnussen, M.D. (PRINCIPAL_INVESTIGATOR)
David Flanigan, M.D. (SUB_INVESTIGATOR)
UT Health San AntonioSan AntonioTexas78249
Jennifer Aguilar
[email protected]
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, CARush University Medical Center· Chicago, ILGenesis Orthopedics & Sports Medicine· Oak Brook, ILUniversity of Nebraska Medical Center· Omaha, NENYU Langone Health· New York, NY

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