The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System)

NCT02136901 | Completed

• 1 other identifier: 00356
• Study Type: interventional
• Target: 34
• Locations: 6 countries
• Sites: 7

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.

Conditions

Meniscectomy; Osteoarthritis

Keywords

NuSurface; Meniscus; Prosthesis; KOOS

Outcome Measures

Primary Outcomes (2)

• KOOS Scale

  The KOOS Pain Subscale and KOOS Overall Scale (Average of the 5 KOOS Subscales) relative to baseline - all at 24 months.

  2 years

• NUsurface Device Related Complications

  The device related complications of the NUsurface Meniscus Implant during the 24-month post-operative period in regard to secondary surgical intervention of the NUsurface device.

  2 years

Study Arms (2)

Investigational arm

EXPERIMENTAL

The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.

Device: NUsurface® Meniscus Implant

Control Arm

ACTIVE COMPARATOR

The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).

Drug: NSAID's and Non-surgical Treatment Options; Drug: Intra-Articular Injections with Corticosteroids; Drug: Intra-Articular Injections with Hyaluronic Acid (HA)

Interventions

NUsurface® Meniscus Implant DEVICE

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 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.

Investigational arm

NSAID's and Non-surgical Treatment Options DRUG

Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise

Control Arm

Intra-Articular Injections with Corticosteroids DRUG

Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).

Control Arm

Intra-Articular Injections with Hyaluronic Acid (HA) DRUG

Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.

Control Arm

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Active Implants: lead

Study Sites (7)

AZ Monica

Antwerp, BE-2018, Belgium

Location

Centre Hospitalier de Versailles

Le Chesnay, F 78158, France

Location

University Hospital of Munich

Munich, 81377, Germany

Location

Ichilov Hospital

Tel Aviv, 64239, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Ospedale Sacro Cuore - Don Calabria

Negrar, Verona, 37024, Italy

Location

Academisch Ziekenhuis Maastricht

Maastricht, 66202, Netherlands

Location

Related Publications (7)

• 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.

  PMID: 24055793 BACKGROUND

• 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.

  PMID: 20635076 BACKGROUND

• 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.

  PMID: 20887018 BACKGROUND

• 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.

  PMID: 20815651 BACKGROUND

• 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.

  PMID: 20370247 BACKGROUND

• 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.

  PMID: 26057364 BACKGROUND

• 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.

  PMID: 25238685 RESULT

MeSH Terms

Conditions

Osteoarthritis

Interventions

Injections, Intra-Articular; Adrenal Cortex Hormones; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 13, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 21, 2022

Record last verified: 2020-07

Locations

BE (1); IT (1); FR (1); DE (1); IL (2); NL (1)