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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
Sponsor:
Information provided by (Responsible Party):
Active Implants

Brief 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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Belgium
AZ Monica
Antwerp, Belgium, BE-2018
France
Centre Hospitalier de Versailles
Le Chesnay CEDEX, France, F 78158
Germany
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
University Hospital of Munich
Munich, Germany, 81377
Universitätklinikum Regensburg
Regensburg, Germany, 93042
Israel
Ichilov Hospital
Tel Aviv, Israel, 64239
Meuhedet HCO
Tel-Aviv, Israel, 62038
Assaf Harofeh Medical Center
Zerifin, Israel, 70300
Italy
Ospedale Sacro Cuore - Don Calabria
Negrar, Verona, Italy, 37024
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 66202
Sweden
Hallands Sjukhus Kungsbacka
Kungsbacka, Halland, Sweden, SE-434 80
Sponsors and Collaborators
Active Implants

Publications of Results:
Other Publications:

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Responsible Party: Active Implants
ClinicalTrials.gov Identifier: NCT02136901     History of Changes
Other Study ID Numbers: 00356
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Keywords provided by Active Implants:
NuSurface
Meniscus
Prosthesis
KOOS
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents