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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NUsurface Meniscus Implant | Experimental | All eligible patients will receive the NUsurface® Meniscus Implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUsurface® Meniscus Implant | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years |
| Clinical Performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard W Treharne, PhD | Active Implants LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Horizon Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25238685 | Background | De Coninck T, Elsner JJ, Linder-Ganz E, Cromheecke M, Shemesh M, Huysse W, Verdonk R, Verstraete K, Verdonk P. In-vivo evaluation of the kinematic behavior of an artificial medial meniscus implant: A pilot study using open-MRI. Clin Biomech (Bristol). 2014 Sep;29(8):898-905. doi: 10.1016/j.clinbiomech.2014.07.001. Epub 2014 Jul 17. | |
| 24055793 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2015 | May 7, 2026 |
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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 |
| 5 years |
| La Mesa |
| California |
| 91942 |
| United States |
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | United States |
| St Mary's Medical Center | San Francisco | California | 94117 | United States |
| CU Sports Medicine | Boulder | Colorado | 80309, 80222, 80045 | United States |
| Advanced Orthopaedics & Sports Medicine Specialists | Denver | Colorado | 80230 | United States |
| OrthoIndy | Greenwood | Indiana | 46143 | United States |
| Baton Rouge Orthopaedic Clinic | Baton Rouge | Louisiana | 70810 | United States |
| Ochsner Sports Medicine Institute | New Orleans | Louisiana | 70121 | United States |
| Sports Medicine Oregon | Portland | Oregon | 97224 | United States |
| Arlington Orthopedic Associates, PA | Arlington | Texas | 76015 | United States |
| Comprehensive Orthopaedics & Sports Medicine | Salt Lake City | Utah | 84102 | United States |
| OrthoVirginia | Richmond | Virginia | 23294 | United States |
| Shemesh M, Asher R, Zylberberg E, Guilak F, Linder-Ganz E, Elsner JJ. Viscoelastic properties of a synthetic meniscus implant. J Mech Behav Biomed Mater. 2014 Jan;29:42-55. doi: 10.1016/j.jmbbm.2013.08.021. Epub 2013 Sep 3. |
| 20635076 | Background | Zur G, Linder-Ganz E, Elsner JJ, Shani J, Brenner O, Agar G, Hershman EB, Arnoczky SP, Guilak F, Shterling A. Chondroprotective effects of a polycarbonate-urethane meniscal implant: histopathological results in a sheep model. Knee Surg Sports Traumatol Arthrosc. 2011 Feb;19(2):255-63. doi: 10.1007/s00167-010-1210-5. Epub 2010 Jul 16. |
| 20887018 | Background | Elsner JJ, Portnoy S, Guilak F, Shterling A, Linder-Ganz E. MRI-based characterization of bone anatomy in the human knee for size matching of a medial meniscal implant. J Biomech Eng. 2010 Oct;132(10):101008. doi: 10.1115/1.4002490. |
| 20815651 | Background | Elsner JJ, Portnoy S, Zur G, Guilak F, Shterling A, Linder-Ganz E. Design of a free-floating polycarbonate-urethane meniscal implant using finite element modeling and experimental validation. J Biomech Eng. 2010 Sep;132(9):095001. doi: 10.1115/1.4001892. |
| 20370247 | Background | Linder-Ganz E, Elsner JJ, Danino A, Guilak F, Shterling A. A novel quantitative approach for evaluating contact mechanics of meniscal replacements. J Biomech Eng. 2010 Feb;132(2):024501. doi: 10.1115/1.4000407. |
| 26057364 | Background | Elsner JJ, Shemesh M, Shefy-Peleg A, Gabet Y, Zylberberg E, Linder-Ganz E. Quantification of in vitro wear of a synthetic meniscus implant using gravimetric and micro-CT measurements. J Mech Behav Biomed Mater. 2015 Sep;49:310-20. doi: 10.1016/j.jmbbm.2015.05.017. Epub 2015 May 28. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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