The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)

NCT02483988 | Unknown DMC FDA Device

• 1 other identifier: 00571
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 13

Brief 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

Keywords

NUsurface; Meniscus; prosthesis; KOOS

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Safety assessed by Serious and non-serious, device-related and non-device related adverse events

  5 years

• Clinical Performance

  5 years

Study Arms (1)

NUsurface Meniscus Implant

EXPERIMENTAL

All eligible patients will receive the NUsurface® Meniscus Implant.

Device: NUsurface® Meniscus Implant

Interventions

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.

NUsurface Meniscus Implant

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Had \> 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
• Has a KOOS Pain of ≤ 75 (100 being the highest attainable and no pain)
• 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
• Is able to do the study required follow-up visits, questionnaires, X-rays and MRI's
• Is able to read and understand the English language if treated at a U.S. site or read and understand one of the official country languages if treated at a site Outside the U.S.
• Is able and willing to understand and sign the Informed Consent Form

You may not qualify if:

• 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 start 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

Sponsors & Collaborators

• Active Implants: lead

Study Sites (13)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Horizon Clinical Research

La Mesa, California, 91942, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

St Mary's Medical Center

San Francisco, California, 94117, United States

Location

CU Sports Medicine

Boulder, Colorado, 80309, 80222, 80045, United States

Location

Advanced Orthopaedics & Sports Medicine Specialists

Denver, Colorado, 80230, United States

Location

OrthoIndy

Greenwood, Indiana, 46143, United States

Location

Baton Rouge Orthopaedic Clinic

Baton Rouge, Louisiana, 70810, United States

Location

Ochsner Sports Medicine Institute

New Orleans, Louisiana, 70121, United States

Location

Sports Medicine Oregon

Portland, Oregon, 97224, United States

Location

Arlington Orthopedic Associates, PA

Arlington, Texas, 76015, United States

Location

Comprehensive Orthopaedics & Sports Medicine

Salt Lake City, Utah, 84102, United States

Location

OrthoVirginia

Richmond, Virginia, 23294, United States

Location

Related Publications (7)

• 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.

  PMID: 25238685 BACKGROUND

• 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.

  PMID: 24055793 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.

  PMID: 20635076 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.

  PMID: 20887018 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.

  PMID: 20815651 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.

  PMID: 20370247 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.

  PMID: 26057364 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Richard W Treharne, PhD

  Active Implants LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: June 29, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-03

Locations

US (13)