CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
NSAID's and Non-surgical Treatment Options +3 moredrug
Likely dose
Intra-Articular Injections with Corticosteroids 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT02136901N/ACompleted
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The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-center, Prospective, Randomized, Interventional, Superiority Clinical Study

Active Implants·interventional·Posted May 13, 2014·Updated Feb 21, 2022

In Brief

A clinical study evaluating NUsurface® Meniscus Implant, NSAID's and Non-surgical Treatment Options, and 2 other interventions for Meniscectomy and Osteoarthritis. Completed, enrolled 34 participants across 7 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeniscectomy, Osteoarthritis
CountriesBelgium, France, Germany, Israel, Italy, Netherlands
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 13, 2014
Enrollment StartJun 1, 2014
Primary CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 12.1 years ago

Interventions

NUsurface® Meniscus Implantdevice

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 Optionsdrug

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 Corticosteroidsdrug

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

Intra-Articular Injections with Hyaluronic Acid (HA)drug

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