Clinical trial NCT02136901: The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System)
Official title: The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-center, Prospective, Randomized, Interventional, Superiority Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscectomy
Osteoarthritis
Keywords: NuSurface
Meniscus
Prosthesis
KOOS
Lead sponsor: Active Implants
Sponsor class: INDUSTRY
First posted: 2014-05-13
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized, interventional clinical trial to test the hypothesis that the NUsurface implant is superior to the non-surgical standard of care in treating the target population.The rationale for performing this clinical study is to gather clinical data to evaluate the safety and effectiveness of the NUsurface device compared to the Standard of Care.

Detailed description: The NUsurface® Meniscus Implant is intended for use in patients with medial compartment pain that have had a previous partial medial meniscectomy.

Patients who meet the inclusion/exclusion criteria will be assigned by balanced randomization into one of two groups: the Meniscus Implants versus non-surgical standard of care. The KOOS (Knee injury and Osteoarthritis Outcome Score) and IKDC (International Knee Documentation Committee) forms will be used to provide a comprehensive evaluation of the patients' pre-intervention and post-intervention condition including activity levels, pain, swelling, locking, stability, support, sports activity, and quality of life assessment.

Eligibility criteria: Inclusion Criteria:

* 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, i.e., 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 to the center of the ankle joint
* Has ≥ 2 mm intact medial meniscal rim capable of being fitted with a NUsurface® device AND is also recommended for the baseline non-surgical (and, if likely to receive benefit, any injection) therapies to be administered in the study.
* Is willing to be entered into either arm of the study: implanted with the NUsurface device OR treated with the recommended control arm therapies.
* Is able to do the study required follow up visits, questionnaires, X-rays, and MRI's
* Is able and willing to understand and sign the study Informed Consent Form
* Is able to read and understand the national language of the country in which the relevant clinical site is located

Exclusion Criteria:

* 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
* Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO)
* Has insufficiency fractures or avascular necrosis of the medial compartment
* Has an active infection or tumor (local or systemic)
* Has any type of knee joint inflammatory disease including Sjogren's syndrome
* Has neuropathic knee osteoarthropathy, also known as Charcot joint
* Has any medical condition that does not allow possible arthroscopy of the knee
* Has neurological deficit (sensory, motor, or reflex)
* Is currently involved in another investigation of the lower extremity
* Anticipates having another lower extremity surgery during the study period
* 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
* Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
* Has received any corticosteroid knee injections ≤ 3 months prior to study treatment
* Has chondrocalcinosis
* Is on immunostimulating or immunosuppressing agents
* 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)
* Is a female who is lactating, expecting, or is intending to become pregnant during the study period
* Is an active smoker
* Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
* Is a prisoner
* Is a patient who has economic incentive not to improve

Primary outcomes:
measure: KOOS Scale
timeFrame: 2 years
measure: NUsurface Device Related Complications
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: AZ Monica
city: Le Chesnay CEDEX
country: France
facility: Centre Hospitalier de Versailles
city: Munich
country: Germany
facility: University Hospital of Munich
city: Tel Aviv
country: Israel
facility: Ichilov Hospital
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore - Don Calabria
state: Verona
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
Study officials:
References:
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.
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.