The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)

Osteoarthritis, Knee Clinical Trial

— SUN  

Official title:

The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant). A Multi-center, Single-arm, Prospective, Open-label, Non-randomized, Observational Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02483988
• Other study ID #: 00571
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Active Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Post-Meniscectomy Pain Syndrome

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.

Locations

Country	Name	City	State
United States	Arlington Orthopedic Associates, PA	Arlington	Texas
United States	Baton Rouge Orthopaedic Clinic	Baton Rouge	Louisiana
United States	CU Sports Medicine	Boulder	Colorado
United States	Advanced Orthopaedics & Sports Medicine Specialists	Denver	Colorado
United States	OrthoIndy	Greenwood	Indiana
United States	Horizon Clinical Research	La Mesa	California
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Ochsner Sports Medicine Institute	New Orleans	Louisiana
United States	Banner University Medical Center Phoenix	Phoenix	Arizona
United States	Sports Medicine Oregon	Portland	Oregon
United States	OrthoVirginia	Richmond	Virginia
United States	Comprehensive Orthopaedics & Sports Medicine	Salt Lake City	Utah
United States	St Mary's Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Active Implants

Country where clinical trial is conducted

United States, 

References & 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, Avon). 2014 Sep;29(8):898-905. doi: 10.1016/j.clinbiomech.2014.07.001. Epub 2014 Jul 17. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Clinical Performance	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