The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)
NCT02483988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115
Last updated 2026-05-11
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
- 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.
Sponsors & Collaborators
-
Active Implants
lead INDUSTRY
Principal Investigators
-
Richard W Treharne, PhD · Active Implants LLC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2020-06-03
- Completion
- 2024-05-29
- FDA Device
- Yes
Countries
- United States
Study Locations
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