The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)

Study Overview
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Brief Summary
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The NUsurface® Meniscus Implant SUN Clinical Trial is a multi-center, single-arm, prospective, open label, non-randomized, observational clinical trial to gather safety and probable clinical benefit data on the NUsurface® Meniscus Implant in treated the target population.

Official Title
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The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant). A Multi-center, Single-arm, Prospective, Open-label, Non-randomized, Observational Clinical Study

Conditions
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Post-Meniscectomy Pain Syndrome, Osteoarthritis, Knee

Intervention / Treatment
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* Device: NUsurface® Meniscus Implant


Participation Criteria
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Eligibility Criteria
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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, 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 Is able to do the study required follow-up visits, questionnaires, X-rays and MRI's Is able to read and understand the English language if treated at a U.S. site or read and understand one of the official country languages if treated at a site Outside the U.S. Is able and willing to understand and sign the Informed Consent Form 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 Certain patient populations that are at high risk for poor healing or outcomes such as patients who have a co-morbidity that reduces life expectancy to less than 36 months Patients who are contraindicated for MRI (i.e., pacemaker, defibrillator, cochlear implants, etc.)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NUsurface Meniscus Implant<br>All eligible patients will receive the NUsurface® Meniscus Implant. | Device: NUsurface® Meniscus Implant<br>* 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 that 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by Serious and non-serious, device-related and non-device related adverse events | Safety assessed by Serious and non-serious, device-related and non-device related adverse events recorded during the implantation, up to 24 months following implantation | 2 years | 
| Clinical Performance | Evaluation of performance defined as NUsurface® Meniscus Implant providing knee pain reduction and improvement in functionality and quality of life up to 24 months post-implantation, as measured by KOOS Pain and KOOS 5 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by Serious and non-serious, device-related and non-device related adverse events | Safety assessed by Serious and non-serious, device-related and non-device related adverse events occurring between 24 and 60 months following implantation | 5 years | 
| Clinical Performance | Evaluation of performance defined as NUsurface® Meniscus Implant providing knee pain reduction and improvement in functionality and quality of life up to 60 months post-implantation, as measured by KOOS Pain and KOOS 5 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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KOOS, NUsurface, Meniscus, prosthesis