CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 127 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.

Search/NCT02108496
NCT02108496N/ACompleted
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The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-centered, Prospective, Randomized, Interventional, Superiority Clinical Study

Active Implants·interventional·Posted Apr 9, 2014·Updated May 6, 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 127 participants across 9 sites.

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
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 9, 2014
Enrollment StartJul 1, 2014
Primary CompletionJun 1, 2021
Study CompletionMay 3, 2022
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 12.2 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.