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COMPLETED
NCT02108496
NA

Verifying the Effectiveness of the NUsurface® System

Sponsor: Active Implants

View on ClinicalTrials.gov

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

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.

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