Meniscus; DegenerationNCT01712191
Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant
A study testing NUsurface Meniscus Implant in people with Meniscus; Degeneration and Osteoarthritis, Knee, run by Phoenix Kinetics at 10 sites in 6 countries.
Trial summary
This is a prospective, multi-center, open label, non-randomized study, evaluating the treating of medial meniscus deficiency with the NUsurface Meniscus Implant. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Meniscus; Degeneration, Osteoarthritis, Knee
- What is being tested?
- NUsurface Meniscus Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Jan 2011to Mar 2016
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic MRI.
- Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal.
- Be in neutral alignment +/- 5 degrees of the mechanical axis.
- Be between age 35 and 75 at the time of the planned surgery.
- Be able to be fitted anatomically with a size 30 to 90 NUsurface® device.
- Have a normal mental status.
- Be willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule.
- Be able and willing to understand and sign the informed consent form.
Who cannot join
- Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the NUsurface implant
- Have lateral compartment pain with lateral articular cartilage damage greater than Grade II (OB), and/or a lateral meniscus tear(s)
- Have a varus or valgus knee deformity > 5 degrees.
- Have a laxity level of more than II (ICRS), secondary to previous 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).
- Have patella instability or non-anatomically positioned patella
- Have patellar compartment pain and/or patellar articular cartilage damage greater than Grade II (OB).
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- Need a tibial osteotomy at the time of surgery.
- Have an ACL reconstruction performed less than 9 months before implanting the NUsurface® device
- Have any type of previously implanted prosthetic meniscus or ligament or knee implant made of plastic.
- Have a knee flexion contracture > 10 degrees
- Be unable to flex the knee to 90 degrees
- Have a leg length discrepancy causing a noticeable limp.
- Have had a previous major knee condyle surgery
- Present with insufficiency fractures or avascular necrosis of the medial compartment.
- Have an active infection or tumor.
- Have any type of knee joint inflammatory disease including Sjogren's syndrome.
- Have neuropathic knee osteoarthropathy, also known as Charcot joint.
- Have any medical condition that does not allow arthroscopy at the point of entry to the knee.
- Be pregnant or is a female intending to become pregnant during the study period.
- Be mentally incapacitated.
- Be a prisoner.
- Be a patient who has economic incentive not to improve (e.g., workman's compensation patient)
- Be morbidly Obese (BMI > 35).
- Is unwilling or unable to have an X-ray, Fluro, or MRI of the affected knee
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Israel3 sites
Emek Medical Center
Afula
Tel Aviv Sourasky Medical Center- Ichilov
Tel Aviv, 64239
Assaf Harofeh Medical Center
Tsrifin
About this study
This is a prospective, multi-center, open label, non-randomized study, evaluating the treating of medial meniscus deficiency with the NUsurface Meniscus Implant.
- Conditions
- Meniscus; Degeneration, Osteoarthritis, Knee
- Being tested
- NUsurface Meniscus Implant
- Keywords
- NUsurface, Meniscus, Knee, KOOS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUsurface Meniscus ImplantDevice
| Study group | Role | What they receive |
|---|---|---|
| NUsurface Meniscus Implant | Experimental | Not described Receives: Device: NUsurface Meniscus Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus; DegenerationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 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
- NCT01712191
- Sponsor's protocol ID
- 00017
- Status last verified
- Aug 2026
- First submitted
- 18 Oct 2012
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant
- ClinicalTrials.gov ID
- NCT01712191
- Acronym / sponsor ID
- 00017
- Conditions
- Meniscus; Degeneration, Osteoarthritis, Knee
- Keywords
- NUsurface, Meniscus, Knee, KOOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Phoenix KineticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Oct 2012 (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.
This is a prospective, multi-center, open label, non-randomized study, evaluating the treating of medial meniscus deficiency with the NUsurface Meniscus Implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NUsurface Meniscus Implant | Experimental | Device: NUsurface Meniscus Implant |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic MRI.
- Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal.
- Be in neutral alignment +/- 5 degrees of the mechanical axis.
- Be between age 35 and 75 at the time of the planned surgery.
- Be able to be fitted anatomically with a size 30 to 90 NUsurface® device.
Key exclusion criteria (24 listed)
- Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the NUsurface implant
- Have lateral compartment pain with lateral articular cartilage damage greater than Grade II (OB), and/or a lateral meniscus tear(s)
- Have a varus or valgus knee deformity > 5 degrees.
- Have a laxity level of more than II (ICRS), secondary to previous 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).
- Have patella instability or non-anatomically positioned patella
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 Implant | Device | NUsurface Meniscus Implant |
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 24 Months
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 31 Aug 2026.
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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.
10 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 in people with Meniscus; Degeneration and Osteoarthritis, Knee, run by Phoenix Kinetics at 10 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 8 inclusion and 24 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Israel, Belgium, Germany, Italy, Netherlands 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?
Knee injury and Osteoarthritis Outcome Score (KOOS) (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.