NCT02483988

The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Active Implants · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-Meniscectomy Pain Syndrome
• Osteoarthritis, Knee

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2015-06-29
• Last updated: 2023-04-18

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study