Print Send My Information

Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Activity exacerbated knee pain isolated to the medial compartment and not global in nature 2. WOMAC pain ≥ 40 3. Failed to find relief in non-surgical treatment modalities

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 sequelae 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
2:1 randomized controlled trial (RCT)
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Randomization is programmed within the Electronic Data Capture system to ensure that the groups are unbiased and that the results are reliable, independent from the participant, investigator, and sponsor. The outcomes assessor remains independent from the participant, investigator and the sponsor.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: 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.
  • Other: 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.

Recruiting Locations

UC Davis Department of Orthopaedic Surgery
Davis, California 95816
Contact:
Leslie Mellor
ljmellor@ucdavis.edu

Scripps Clinic Jefferson
Oceanside, California 92054
Contact:
Joy Biggers
858-554-7980

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Carla Edwards
carla_edwards@rush.edu

NYU Langone Health
New York, New York 10016
Contact:
Ivanka Bhambhani
646-831-8314

Ohio State Jameson Crane Sports Medicine Institute
Columbus, Ohio 43202
Contact:
Jenna DeFranco
614-366-9372
Jenna.defranco@osumc.edu

More Details

NCT ID
NCT06843980
Status
Recruiting
Sponsor
Moximed

Study Contact

Rose S Weinstein
4153120255
rsweinstein@moximed.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center