Clinical trial NCT02483988: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Meniscectomy Pain Syndrome
Osteoarthritis, Knee
Keywords: NUsurface
Meniscus
prosthesis
KOOS
Lead sponsor: Active Implants
Sponsor class: INDUSTRY
First posted: 2015-06-29
Enrollment: 115
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.)

Primary outcomes:
measure: Safety assessed by Serious and non-serious, device-related and non-device related adverse events
timeFrame: 2 years
measure: Clinical Performance
timeFrame: 2 years
Secondary outcomes:
measure: Safety assessed by Serious and non-serious, device-related and non-device related adverse events
timeFrame: 5 years
measure: Clinical Performance
timeFrame: 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
city: La Mesa
country: United States
facility: Horizon Clinical Research
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: San Francisco
country: United States
facility: St Mary's Medical Center
state: California
city: Boulder
country: United States
facility: CU Sports Medicine
state: Colorado
city: Denver
country: United States
facility: Advanced Orthopaedics & Sports Medicine Specialists
state: Colorado
city: Greenwood
country: United States
facility: OrthoIndy
state: Indiana
city: Baton Rouge
country: United States
facility: Baton Rouge Orthopaedic Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Sports Medicine Institute
state: Louisiana
city: Portland
country: United States
facility: Sports Medicine Oregon
state: Oregon
city: Arlington
country: United States
facility: Arlington Orthopedic Associates, PA
state: Texas
city: Salt Lake City
country: United States
facility: Comprehensive Orthopaedics & Sports Medicine
state: Utah
city: Richmond
country: United States
facility: OrthoVirginia
state: Virginia
Study officials:
affiliation: Active Implants LLC
name: Richard W Treharne, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.