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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
115
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.
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Horizon Clinical Research
La Mesa, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
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
Time frame: 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
Time frame: 2 years
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
Time frame: 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
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St Mary's Medical Center
San Francisco, California, United States
CU Sports Medicine
Boulder, Colorado, United States
Advanced Orthopaedics & Sports Medicine Specialists
Denver, Colorado, United States
OrthoIndy
Greenwood, Indiana, United States
Baton Rouge Orthopaedic Clinic
Baton Rouge, Louisiana, United States
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States
Sports Medicine Oregon
Portland, Oregon, United States
...and 3 more locations