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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02483988
Recruitment Status : Active, not recruiting
First Posted : June 29, 2015
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Active Implants

Tracking Information
First Submitted Date  ICMJE June 25, 2015
First Posted Date  ICMJE June 29, 2015
Last Update Posted Date August 2, 2021
Actual Study Start Date  ICMJE December 2015
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Post-Meniscectomy Pain Syndrome
  • Osteoarthritis, Knee
Intervention  ICMJE 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  ICMJE Experimental: NUsurface Meniscus Implant
All eligible patients will receive the NUsurface® Meniscus Implant.
Intervention: Device: NUsurface® Meniscus Implant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 19, 2019)
115
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2015)
118
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02483988
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Active Implants
Study Sponsor  ICMJE Active Implants
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard W Treharne, PhD Active Implants LLC
PRS Account Active Implants
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP