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

February 18, 2022 updated by: Active Implants

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, BE-2018
        • AZ Monica
  • France
      • Le Chesnay CEDEX, France, F 78158
        • Centre Hospitalier de Versailles
  • Germany
      • Munich, Germany, 81377
        • University Hospital of Munich
  • Israel
      • Tel Aviv, Israel, 64239
        • Ichilov Hospital
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center
  • Italy
    • Verona
      • Negrar, Verona, Italy, 37024
        • Ospedale Sacro Cuore - Don Calabria
  • Netherlands
      • Maastricht, Netherlands, 66202
        • Academisch Ziekenhuis Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Had > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
  • Has a KOOS Pain of ≤ 75 (100 being the highest attainable and no pain)
  • Is between age 30 and 75 years (inclusive) at the time of study treatment
  • Has neutral alignment ± 5º of the mechanical axis, i.e., the angle formed by a line drawn from the center of the femoral head to the medial tibial spine and a line drawn from the medial tibial spine to the center of the ankle joint
  • Has ≥ 2 mm intact medial meniscal rim capable of being fitted with a NUsurface® device AND is also recommended for the baseline non-surgical (and, if likely to receive benefit, any injection) therapies to be administered in the study.
  • Is willing to be entered into either arm of the study: implanted with the NUsurface device OR treated with the recommended control arm therapies.
  • Is able to do the study required follow up visits, questionnaires, X-rays, and MRI's
  • Is able and willing to understand and sign the study Informed Consent Form
  • Is able to read and understand the national language of the country in which the relevant clinical site is located

Exclusion Criteria:

  • Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy leaving > 4 mm of medial meniscus rim
  • Has evidence of a Outerbridge Grade IV cartilage loss on the medial tibial plateau or femoral condyle that potentially could contact a NUsurface implant (e.g., a focal lesion > 0.5 cm2 correlating to a circular defect of > 8 mm in diameter)
  • Has complete disruption of the posterior root attachment of the meniscus
  • Has lateral compartment pain and Grade III or Grade IV Outerbridge cartilage score in the lateral compartment
  • Has a varus or valgus knee deformity > 5º requiring a tibial or femoral osteotomy
  • Has a laxity level of more than Grade II (IKDC), primary or secondary to an injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL)
  • Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment
  • Has patellar compartment pain and Grade III or Grade IV Outerbridge cartilage score in the patellar compartment.
  • Compared to a normal knee, has obvious radiological evidence of medial femoral squaring, anatomical variance in the medial tibial plateau, or irregularly shaped cartilage surface
  • Had an ACL reconstruction performed < 9 months prior to study treatment
  • Has a BMI > 32.5 at the start of study treatment
  • Decides to receive (if eligible and an option) allograft medial meniscus transplantation
  • Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the NUsurface® Meniscus Implant
  • Has a knee flexion contracture > 10º
  • Has flexion < 90º
  • Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO)
  • Has insufficiency fractures or avascular necrosis of the medial compartment
  • Has an active infection or tumor (local or systemic)
  • Has any type of knee joint inflammatory disease including Sjogren's syndrome
  • Has neuropathic knee osteoarthropathy, also known as Charcot joint
  • Has any medical condition that does not allow possible arthroscopy of the knee
  • Has neurological deficit (sensory, motor, or reflex)
  • Is currently involved in another investigation of the lower extremity
  • Anticipates having another lower extremity surgery during the study period
  • Is contraindicated for hyaluronic acid injections (i.e., patients with known hypersensitivity [allergy] to hyaluronan [sodium hyaluoronate] preparations); patients having knee joint infections or skin diseases or infections in the site of possible injections
  • Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
  • Has received any corticosteroid knee injections ≤ 3 months prior to study treatment
  • Has chondrocalcinosis
  • Is on immunostimulating or immunosuppressing agents
  • Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or KOOS (e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing a noticeable limp)
  • Is a female who is lactating, expecting, or is intending to become pregnant during the study period
  • Is an active smoker
  • Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
  • Is a prisoner
  • Is a patient who has economic incentive not to improve

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Active Implants

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00356

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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