MeniscectomyVENUSNCT02136901
The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System)
A study testing NUsurface® Meniscus Implant, NSAID's and Non-surgical Treatment Options and Intra-Articular Injections with Corticosteroids in people with Meniscectomy and Osteoarthritis, run by Phoenix Kinetics at 7 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Meniscectomy, Osteoarthritis
- What is being tested?
- NUsurface® Meniscus Implant, NSAID's and Non-surgical Treatment Options and Intra-Articular Injections with Corticosteroids
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Jun 2014to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 35Show fewer
- 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
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Israel2 sites
Ichilov Hospital
Tel Aviv, 64239
Assaf Harofeh Medical Center
Tsrifin, 70300
About this study
Official title: The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-center, Prospective, Randomized, Interventional, Superiority Clinical Study
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.
Read the 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.
- Conditions
- Meniscectomy, Osteoarthritis
- Being tested
- NUsurface® Meniscus Implant, NSAID's and Non-surgical Treatment Options, Intra-Articular Injections with Corticosteroids, Intra-Articular Injections with Hyaluronic Acid (HA)
- Keywords
- NuSurface, Meniscus, Prosthesis, KOOS
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUsurface® Meniscus ImplantDevice
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.
NSAID's and Non-surgical Treatment OptionsDrug
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
Intra-Articular Injections with CorticosteroidsDrug
Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-Articular Injections with Hyaluronic Acid (HA)Drug
Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
| Study group | Role | What they receive |
|---|---|---|
| Investigational arm | Experimental | The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant. Receives: 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). Receives: Drug: NSAID's and Non-surgical Treatment Options; Drug: Intra-Articular Injections with Corticosteroids; Drug: Intra-Articular Injections with Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS Scale
The KOOS Pain Subscale and KOOS Overall Scale (Average of the 5 KOOS Subscales) relative to baseline - all at 24 months.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MeniscectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Kinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136901
- Sponsor's protocol ID
- 00356
- Acronym
- VENUS
- Status last verified
- Jul 2020
- First submitted
- 9 May 2014
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24055793Zur 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.
PubMed 20635076Elsner 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.
PubMed 20887018Elsner 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.
PubMed 20815651Linder-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.
PubMed 20370247Elsner 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.
PubMed 26057364De 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.
PubMed 25238685
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-center, Prospective, Randomized, Interventional, Superiority Clinical Study
- ClinicalTrials.gov ID
- NCT02136901
- Acronym / sponsor ID
- VENUS / 00356
- Conditions
- Meniscectomy, Osteoarthritis
- Keywords
- NuSurface, Meniscus, Prosthesis, KOOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Phoenix KineticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational arm | Experimental | Device: NUsurface® Meniscus ImplantThe patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant. |
| Control Arm | Active comparator | Drug: NSAID's and Non-surgical Treatment Options, Drug: Intra-Articular Injections with Corticosteroids, Drug: Intra-Articular Injections with Hyaluronic Acid (HA)The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population). |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUsurface® Meniscus ImplantThe 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. | Device | Investigational arm |
| NSAID's and Non-surgical Treatment OptionsNon-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise | Drug | Control Arm |
| Intra-Articular Injections with CorticosteroidsIntra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog). | Drug | Control Arm |
| Intra-Articular Injections with Hyaluronic Acid (HA)Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections. | Drug | Control Arm |
Primary outcome
KOOS Scale
Time frame: 2 years
The KOOS Pain Subscale and KOOS Overall Scale (Average of the 5 KOOS Subscales) relative to baseline - all at 24 months.
NUsurface Device Related Complications
Time frame: 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Background: PubMed 24055793Shemesh 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.
- Background: PubMed 20635076Zur 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.
- Background: PubMed 20887018Elsner 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.
- Background: PubMed 20815651Elsner 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.
- Background: PubMed 20370247Linder-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.
- Background: PubMed 26057364Elsner 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.
- Results publication: PubMed 25238685De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUsurface® Meniscus Implant, NSAID's and Non-surgical Treatment Options and Intra-Articular Injections with Corticosteroids in people with Meniscectomy and Osteoarthritis, run by Phoenix Kinetics at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel, Belgium, France, Germany, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS Scale (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136901, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.