The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) (VENUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02136901|
Recruitment Status : Active, not recruiting
First Posted : May 13, 2014
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Meniscectomy Osteoarthritis||Device: NUsurface® Meniscus Implant Drug: NSAID's and Non-surgical Treatment Options Drug: Intra-Articular Injections with Corticosteroids Drug: Intra-Articular Injections with Hyaluronic Acid (HA)||Not Applicable|
The NUsurface® Meniscus Implant is intended for use in patients with medial compartment pain that have had a previous partial medial meniscectomy.
Patients who meet the inclusion/exclusion criteria will be assigned by balanced randomization into one of two groups: the Meniscus Implants versus non-surgical standard of care. The KOOS (Knee injury and Osteoarthritis Outcome Score) and IKDC (International Knee Documentation Committee) forms will be used to provide a comprehensive evaluation of the patients' pre-intervention and post-intervention condition including activity levels, pain, swelling, locking, stability, support, sports activity, and quality of life assessment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-center, Prospective, Randomized, Interventional, Superiority Clinical Study|
|Actual Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Investigational arm
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
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.
Active Comparator: Control Arm
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
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.
- KOOS Scale [ Time Frame: 2 years ]The KOOS Pain Subscale and KOOS Overall Scale (Average of the 5 KOOS Subscales) relative to baseline — all at 24 months.
- NUsurface Device Related Complications [ Time Frame: 2 years ]The device related complications of the NUsurface Meniscus Implant during the 24-month post-operative period in regard to secondary surgical intervention of the NUsurface device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136901
|Antwerp, Belgium, BE-2018|
|Centre Hospitalier de Versailles|
|Le Chesnay CEDEX, France, F 78158|
|Freiburg, Germany, 79106|
|University Hospital of Munich|
|Munich, Germany, 81377|
|Regensburg, Germany, 93042|
|Tel Aviv, Israel, 64239|
|Tel-Aviv, Israel, 62038|
|Assaf Harofeh Medical Center|
|Zerifin, Israel, 70300|
|Ospedale Sacro Cuore - Don Calabria|
|Negrar, Verona, Italy, 37024|
|Academisch Ziekenhuis Maastricht|
|Maastricht, Netherlands, 66202|
|Hallands Sjukhus Kungsbacka|
|Kungsbacka, Halland, Sweden, SE-434 80|