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Verifying the Effectiveness of the NUsurface® System
Sponsor: Active Implants
Summary
The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized, interventional clinical trial to test the hypothesis that the NUsurface implant is superior to the non-surgical standard of care in treating the target population.The rationale for performing this clinical study is to gather clinical data to evaluate the safety and effectiveness of the NUsurface device compared to the Standard of Care.
Official title: The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-centered, Prospective, Randomized, Interventional, Superiority Clinical Study
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
337
Start Date
2014-07
Completion Date
2022-05-03
Last Updated
2026-07-28
Healthy Volunteers
No
Conditions
Interventions
NUsurface® Meniscus Implant
The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
NSAID's and Non-surgical Treatment Options
Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Intra-Articular Injections with Corticosteroids
Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA)
Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
Locations (9)
OrthoIndy
Indianapolis, Indiana, United States
Brigham and Woman's Hospital
Boston, Massachusetts, United States
New England Baptist Hospital
Roxbury Crossing, Massachusetts, United States
Capital Region Orthopaedics
Albany, New York, United States
Lenox Hill Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
OrthoSouth
Memphis, Tennessee, United States
Advanced Orthopaedics
Richmond, Virginia, United States