VENUS: Verifying the Effectiveness of the NUsurface® System

Sponsor

Active Implants (Industry)

Overall Status

Completed

CT.gov ID

NCT02108496

Collaborator

(none)

127

Enrollment

Locations

Arms

94.1

Actual Duration (Months)

14.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

127 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-centered, Prospective, Randomized, Interventional, Superiority Clinical Study

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

May 3, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

KOOS Scale [2 years]
The KOOS Pain Subscale and KOOS Overall Scale (Average of the 5 KOOS Subscales) relative to baseline - all at 24 months.
NUsurface Device Related Complications [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.

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
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 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 time 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 hyaluronate] 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OrthoIndy	Indianapolis	Indiana	United States	46143
2	Brigham and Woman's Hospital	Boston	Massachusetts	United States	02115
3	New England Baptist Hospital	Roxbury Crossing	Massachusetts	United States	02120
4	Capital Region Orthopaedics	Albany	New York	United States	12206
5	Lenox Hill Hospital	New York	New York	United States	10075
6	Duke University Medical Center	Durham	North Carolina	United States	27710
7	Ohio State University Medical Center	Columbus	Ohio	United States	43221
8	OrthoSouth	Memphis	Tennessee	United States	38120
9	Advanced Orthopaedics	Richmond	Virginia	United States	23294