The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)

Sponsor

Active Implants (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02483988

Collaborator

(none)

115

Enrollment

Locations

Arm

Anticipated Duration (Months)

8.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Meniscectomy Pain Syndrome Osteoarthritis, Knee	Device: NUsurface® Meniscus Implant	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NUsurface Meniscus Implant All eligible patients 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 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.

Arm

Intervention/Treatment

Experimental: NUsurface Meniscus Implant

All eligible patients 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 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.

Outcome Measures

Primary Outcome Measures

Safety assessed by Serious and non-serious, device-related and non-device related adverse events [2 years]
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
Clinical Performance [2 years]
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

Secondary Outcome Measures

Safety assessed by Serious and non-serious, device-related and non-device related adverse events [5 years]
Safety assessed by Serious and non-serious, device-related and non-device related adverse events occurring between 24 and 60 months following implantation
Clinical Performance [5 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner University Medical Center Phoenix	Phoenix	Arizona	United States	85006
2	Horizon Clinical Research	La Mesa	California	United States	91942
3	Long Beach Memorial Medical Center	Long Beach	California	United States	90806
4	St Mary's Medical Center	San Francisco	California	United States	94117
5	CU Sports Medicine	Boulder	Colorado	United States	80309, 80222, 80045
6	Advanced Orthopaedics & Sports Medicine Specialists	Denver	Colorado	United States	80230
7	OrthoIndy	Greenwood	Indiana	United States	46143
8	Baton Rouge Orthopaedic Clinic	Baton Rouge	Louisiana	United States	70810
9	Ochsner Sports Medicine Institute	New Orleans	Louisiana	United States	70121
10	Sports Medicine Oregon	Portland	Oregon	United States	97224
11	Arlington Orthopedic Associates, PA	Arlington	Texas	United States	76015
12	Comprehensive Orthopaedics & Sports Medicine	Salt Lake City	Utah	United States	84102
13	OrthoVirginia	Richmond	Virginia	United States	23294