MeniscectomyVENUSNCT02108496
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 9 sites in United States.
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
- 337 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2014to 3 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Is between age 30 and 75 years (inclusive) at the time of study treatment
- 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
- 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 willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule
Show all 9Show fewer
- Is able and willing to understand and sign the Informed Consent Form
- Is able to read and understand the English language
- Has a KOOS Pain of ≤ 75 (100 being the highest attainable and no pain)
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 time 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 hyaluronate] 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
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Capital Region Orthopaedics
Albany, New York, 12206
Brigham and Woman's Hospital
Boston, Massachusetts, 02115
Ohio State University Medical Center
Columbus, Ohio, 43221
Duke University Medical Center
Durham, North Carolina, 27710
OrthoIndy
Indianapolis, Indiana, 46143
OrthoSouth
Memphis, Tennessee, 38120
Lenox Hill Hospital
New York, New York, 10075
Advanced Orthopaedics
Richmond, Virginia, 23294
New England Baptist Hospital
Roxbury Crossing, Massachusetts, 02120
About this study
Official title: The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-centered, 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
- meniscectomy, meniscus, implant, koos, nusurface
- 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 | Experimental | The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant. Receives: Device: NUsurface® Meniscus Implant |
| Control | 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.
Overall Success Composite Endpoint
Overall Success is a composite endpoint computed at 24-Months whereby a subject must satisfy the pre-defined KOOS goals (KOOS Success), must have completed 24 Months with no disqualifying surgical intervention, and must have completed 24 Months with no device fracture and no subluxation on MRI confirmation.
Measured: 2 years
Automatic Study Failure
The automatic treatment failure of the Control Group during the first 24-month period is any surgical intervention of the index knee. The automatic treatment failure of the Investigational Group during the first 24-month period is device removal or MRI detection of a dislocation or device fracture.
Measured: 2 Years
KOOS Success
KOOS Success is an element that contributes to Overall Success by computing KOOS Pain Subscale at 24 months compared to baseline, and KOOS Overall score at 24 months compared to baseline. Scores for each of the five subscales are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. For a subject to have KOOS Success their KOOS measures must be: KOOSpain ≥ 86.1 at 24 Months AND KOOSoverall ≥ 86.2 at 24 Months. Alternatively, a subject can have KOOS Success if KOOSpain ∆ (improvement from Baseline) ≥ 20 points at 24 Months AND KOOSoverall ∆ ≥ 20 points at 24 Months AND KOOSpain ≥ 40 points at 24 Months.
Measured: 2 years
Secondary outcomes (9)
KOOS Subscale - Pain
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Measured: 2 Years
KOOS Subscale - Symptoms
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Measured: 2 Years
KOOS Subscale - ADL
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Measured: 2 Years
KOOS Subscale - Sports and Recreation
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Measured: 2 Years
KOOS Subscale - Quality of Life
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Measured: 2 Years
KOOS Overall Score
Average of all 5 KOOS Subscales
Measured: 2 Years
VAS Pain Score
Visual Analog Scale (VAS) Pain Score is scored from the best lowest score of 0 to the worse pain score of 100.
Measured: 2 Years
WOMET Normalized Score
Western Ontario Meniscal Evaluation Tool is a disease specific quality of life measurement tool for patients with meniscal lesions. Each question is scored from 0 (most favorable condition) to 100 (least favorable condition).
When combining all scores from the 16 possible questions, the best and least symptomatic score is 0, and the highest and most symptomatic score possible is 1600. The score may be reported as a total overall score, as a total score for each domain, or as a percentage of normal by subtracting the total score from 1600, dividing by 1600, and multiplying by 100. If the normalized score is used, then the least favorable condition is 0 and the most favorable condition is 100.
Measured: 2 Years
IKDC Subjective Knee Score
The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form is a patient-reported measure of knee symptoms, function, and sports activity. The total score ranges from 0 to 100, where 0 represents the worst symptoms/function and 100 represents the best; higher scores indicate a better outcome. The score is calculated by summing responses to the 18 items, then transforming to a 0-100 scale using: [(raw score - lowest possible raw score) / range of raw score] × 100. No subscale scores are reported.
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 posted9 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2021
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Kinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elliott B Hershman, MD, Principal investigator, Lenox Hill Hospital NYC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108496
- Sponsor's protocol ID
- 000249
- Acronym
- VENUS
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2014
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- 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 22 Sep 2026. 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-centered, Prospective, Randomized, Interventional, Superiority Clinical Study
- ClinicalTrials.gov ID
- NCT02108496
- Acronym / sponsor ID
- VENUS / 000249
- Conditions
- Meniscectomy, Osteoarthritis
- Keywords
- meniscectomy, meniscus, implant, koos, nusurface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Phoenix KineticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Posted 28 Jul 2026
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 | Experimental | Device: NUsurface® Meniscus ImplantThe patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant. |
| Control | 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
- Is between age 30 and 75 years (inclusive) at the time of study treatment
- 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
- 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.
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 |
| 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 |
| Intra-Articular Injections with CorticosteroidsIntra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog). | Drug | Control |
| Intra-Articular Injections with Hyaluronic Acid (HA)Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections. | Drug | Control |
Primary outcome
Overall Success Composite Endpoint
Time frame: 2 years
Overall Success is a composite endpoint computed at 24-Months whereby a subject must satisfy the pre-defined KOOS goals (KOOS Success), must have completed 24 Months with no disqualifying surgical intervention, and must have completed 24 Months with no device fracture and no subluxation on MRI confirmation.
Automatic Study Failure
Time frame: 2 Years
The automatic treatment failure of the Control Group during the first 24-month period is any surgical intervention of the index knee. The automatic treatment failure of the Investigational Group during the first 24-month period is device removal or MRI detection of a dislocation or device fracture.
KOOS Success
Time frame: 2 years
KOOS Success is an element that contributes to Overall Success by computing KOOS Pain Subscale at 24 months compared to baseline, and KOOS Overall score at 24 months compared to baseline. Scores for each of the five subscales are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. For a subject to have KOOS Success their KOOS measures must be: KOOSpain ≥ 86.1 at 24 Months AND KOOSoverall ≥ 86.2 at 24 Months. Alternatively, a subject can have KOOS Success if KOOSpain ∆ (improvement from Baseline) ≥ 20 points at 24 Months AND KOOSoverall ∆ ≥ 20 points at 24 Months AND KOOSpain ≥ 40 points at 24 Months.
9 secondary outcomes
KOOS Subscale - Pain
Time frame: 2 Years
KOOS Subscale - Symptoms
Time frame: 2 Years
KOOS Subscale - ADL
Time frame: 2 Years
KOOS Subscale - Sports and Recreation
Time frame: 2 Years
KOOS Subscale - Quality of Life
Time frame: 2 Years
KOOS Overall Score
Time frame: 2 Years
VAS Pain Score
Time frame: 2 Years
WOMET Normalized Score
Time frame: 2 Years
IKDC Subjective Knee Score
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: No
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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.
Elliott B Hershman, MD principal investigator
Lenox Hill Hospital NYC
9 sites in 1 country: 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 9 sites in United States.
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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Success Composite Endpoint (time frame: 2 years). The study lists 3 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 NCT02108496, 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 22 Sep 2026.