The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System)

NACompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

June 30, 2020

Study Completion Date

June 30, 2020

Conditions
MeniscectomyOsteoarthritis
Interventions
DEVICE

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.

DRUG

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

DRUG

Intra-Articular Injections with Corticosteroids

Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).

DRUG

Intra-Articular Injections with Hyaluronic Acid (HA)

Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.

Trial Locations (7)

37024

Ospedale Sacro Cuore - Don Calabria, Negrar

64239

Ichilov Hospital, Tel Aviv

66202

Academisch Ziekenhuis Maastricht, Maastricht

70300

Assaf Harofeh Medical Center, Ẕerifin

81377

University Hospital of Munich, Munich

BE-2018

AZ Monica, Antwerp

F 78158

Centre Hospitalier de Versailles, Le Chesnay

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Active Implants

INDUSTRY

NCT02136901 - The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) | Biotech Hunter | Biotech Hunter