Verifying the Effectiveness of the NUsurface® System

Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Age Range:30 - 75
Start Date:July 2014
End Date:December 2018
Contact:Jonathan J Elsner, PhD

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The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-centered, 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.

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.

Inclusion Criteria:

- Had > 6 months ago a medial partial meniscectomy as confirmed by patient history and

- Is between age 30 and 75 years (inclusive) at the time of study treatment

- Has neutral alignment ±5º of the mechanical axis, as measured from 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 and 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 willing and able to attend all follow up visits, complete all study
questionnaires, and undergo required X-ray and MRI schedule

- Is able and willing to understand and sign the Informed Consent Form

- Is able to read and understand the English language

- Has a KOOS Pain of ≤ 75 (100 being the highest attainable and no pain)

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

- 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 time of study treatment

- Decides to receive (if eligible and an option) allograft medial meniscus

- 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 hyaluronate] preparations); patients
having knee joint infections or skin diseases or infections in the site of possible

- 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
We found this trial at
New York City, New York 10075
Principal Investigator: Elliott B Hershman, MD
Phone: 212-744-8114
New York City, NY
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Michael Maloney, MD
Phone: 585-341-9305
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
Rochester, NY
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Albany, New York 12206
Principal Investigator: Richard Alfred, MD
Phone: 518-489-2666
Albany, NY
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Boston, Massachusetts 02215
Principal Investigator: Andreas Gomoll, MD
Phone: 617-732-4070
Boston, MA
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Columbus, Ohio 43210
Principal Investigator: Christopher C Kaeding, MD
Phone: 614-293-2761
Columbus, OH
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2301 Erwin Rd
Durham, North Carolina 27710
Principal Investigator: William Garrett, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Durham, NC
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Indianapolis, Indiana
Principal Investigator: Jack Farr, MD
Phone: 317-884-5230
Indianapolis, IN
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Memphis, Tennessee 38120
Principal Investigator: Randall Holcomb, MD
Phone: 901-259-1685
Memphis, TN
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Richmond, Virginia 23294
Phone: 804-270-1305
Richmond, VA
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Roxbury Crossing, Massachusetts 02120
Principal Investigator: Brian McKeon, MD
Phone: 617-754-5696
Roxbury Crossing, MA
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