The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant) (SUN)

• ClinicalTrials.gov Identifier: NCT02483988
• Recruitment Status: Active, not recruiting
• First Posted: June 29, 2015
• Last Update Posted: February 21, 2022
• Sponsor: Active Implants
• Information provided by (Responsible Party): Active Implants

Tracking Information

• First Submitted Date: June 25, 2015
• First Posted Date: June 29, 2015
• Last Update Posted Date: February 21, 2022
• Actual Study Start Date: December 2015
• Actual Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 26, 2021)

• Safety assessed by Serious and non-serious, device-related and non-device related adverse events [ Time Frame: 2 years ]
  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
• Clinical Performance [ Time Frame: 2 years ]
  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

Original Primary Outcome Measures (submitted: June 26, 2015)

• 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 [ Time Frame: 2 years ]
  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

Current Secondary Outcome Measures (submitted: July 26, 2021)

• Safety assessed by Serious and non-serious, device-related and non-device related adverse events [ Time Frame: 5 years ]
  Safety assessed by Serious and non-serious, device-related and non-device related adverse events occurring between 24 and 60 months following implantation
• Clinical Performance [ Time Frame: 5 years ]
  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

Original Secondary Outcome Measures (submitted: June 26, 2015)

• 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 [ Time Frame: 5 years ]
  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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)
• Official Title: The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant). A Multi-center, Single-arm, Prospective, Open-label, Non-randomized, Observational Clinical Study
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Post-Meniscectomy Pain Syndrome
• Osteoarthritis, Knee

Intervention

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.

Study Arms

Experimental: NUsurface Meniscus Implant

All eligible patients will receive the NUsurface® Meniscus Implant.

Intervention: Device: NUsurface® Meniscus Implant

Publications *

• 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, Avon). 2014 Sep;29(8):898-905. doi: 10.1016/j.clinbiomech.2014.07.001. Epub 2014 Jul 17.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 19, 2019): 115
• Original Estimated Enrollment (submitted: June 26, 2015): 118
• Estimated Study Completion Date: June 2023
• Actual Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Had > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
2. Has a KOOS Pain of ≤ 75 (100 being the highest attainable and no pain)
3. Is between age 30 and 75 years (inclusive) at the time of study treatment
4. 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
5. Has ≥ 2 mm intact medial meniscal rim capable of being fitted with a NUsurface® device
6. Is able to do the study required follow-up visits, questionnaires, X-rays and MRI's
7. 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.
8. Is able and willing to understand and sign the Informed Consent Form

Exclusion Criteria:

1. Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy leaving > 4 mm of medial meniscus rim
2. 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)
3. Has complete disruption of the posterior root attachment of the meniscus
4. Has lateral compartment pain and Grade III or Grade IV Outerbridge cartilage score in the lateral compartment
5. Has a varus or valgus knee deformity > 5º requiring a tibial or femoral osteotomy
6. 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)
7. Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment
8. Has patellar compartment pain and Grade III or Grade IV Outerbridge cartilage score in the patellar compartment.
9. 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
10. Had an ACL reconstruction performed < 9 months prior to study treatment
11. Has a BMI > 32.5 at the start of study treatment
12. Decides to receive (if eligible and an option) allograft medial meniscus transplantation
13. Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the NUsurface® Meniscus Implant
14. Has a knee flexion contracture > 10º
15. Has flexion < 90º
16. Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO)
17. Has insufficiency fractures or avascular necrosis of the medial compartment
18. Has an active infection or tumor (local or systemic)
19. Has any type of knee joint inflammatory disease including Sjogren's syndrome
20. Has neuropathic knee osteoarthropathy, also known as Charcot joint
21. Has any medical condition that does not allow possible arthroscopy of the knee
22. Has neurological deficit (sensory, motor, or reflex)
23. Is currently involved in another investigation of the lower extremity
24. Anticipates having another lower extremity surgery during the study period
25. Is contraindicated for hyaluronic acid injections (i.e., patients with known hypersensitivity [allergy] to hyaluronan [sodium hyaluoronate] preparations); patients having knee joint infections or skin diseases or infections in the site of possible injections
26. Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
27. Has received any corticosteroid knee injections ≤ 3 months prior to study treatment
28. Has chondrocalcinosis
29. Is on immunostimulating or immunosuppressing agents
30. Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or KOOS (e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing a noticeable limp)
31. Is a female who is lactating, expecting, or is intending to become pregnant during the study period
32. Is an active smoker
33. Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
34. Is a prisoner
35. Is a patient who has economic incentive not to improve
36. Certain patient populations that are at high risk for poor healing or outcomes such as patients who have a co-morbidity that reduces life expectancy to less than 36 months
37. Patients who are contraindicated for MRI (i.e., pacemaker, defibrillator, cochlear implants, etc.)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02483988
• Other Study ID Numbers: 00571
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Active Implants
• Original Responsible Party: Same as current
• Current Study Sponsor: Active Implants
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Richard W Treharne, PhD; Active Implants LLC

• PRS Account: Active Implants
• Verification Date: February 2022