Meniscus; DegenerationNIRNCT03953846
NUsurface Implant Registry
An observational study of Meniscus; Degeneration and Knee Osteoarthritis, run by Phoenix Kinetics at 6 sites in 4 countries.
Trial summary
The purpose of this active post-market surveillance clinical registry study is to further characterize the therapeutic effect, the long-term safety and effectiveness of the NUsurface® meniscus implant in the real-world post-marketing setting Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Meniscus; Degeneration, Knee Osteoarthritis, Knee Pain Chronic
- How many people
- 36 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 1 Jun 2019to 1 Nov 2023
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population eligible for this protocol includes any subject who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria
Who may be able to join
- New or current treatment with the NUsurface® meniscus implant
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the Registry.
Who cannot join
- There are no protocol exclusion criteria; all subjects who meet the inclusion criteria are eligible for enrollment.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany3 sites
Sporthopaedicum
Berlin, 10627
University of Brandenburg
Brandenburg an der Havel, 14770
Klinikum der Universität München
München, 81377
About this study
Official title: A Long-term Non-interventional Registry Study to Assess the Effectiveness and Safety of the NUsurface® Meniscus Implant
The purpose of this active post-market surveillance clinical registry study is to further characterize the therapeutic effect, the long-term safety and effectiveness of the NUsurface® meniscus implant in the real-world post-marketing setting
Read the detailed description
Patients eligible for the Registry includes any patient who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria (Evidence of a personally signed and dated informed consent document). The NUsurface Implant Regitstry is about data collection only and under routine standard of care by treating physician. Data collection points are pre-op (i.e. baseline), surgery and multiple times after surgery during the first 6 months to correspond to clinic standard of care schedules, 6 months, 1 year post-operatively and then yearly thereafter out to 10 years.Surveys used are KOOS; Knee injury and Osteoarthritis Outcome Score \& WOMET; Western Ontario Meniscal Evaluation Tool.
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS (Knee Osteoarthritis Outcome Score) Pain improvement
a responder is defined as a patient with an increase of at least 20 points on the KOOS pain assessment
Measured: 24 months
WOMET (Western Ontario Meniscus Evaluation Tool) score improvement
a responder is defined as a patient with an increase of at least 12 points on the WOMET assessment
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 posted17 May 2019
- Study start1 Jun 2019
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Why it stopped: Active Implants Europe closed operations
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Phoenix Kinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Belaney, MSBME, Study director, Phoenix Kinetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953846
- Sponsor's protocol ID
- 01003
- Acronym
- NIR
- Status last verified
- Sep 2026
- First submitted
- 15 May 2019
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Non-interventional Registry Study to Assess the Effectiveness and Safety of the NUsurface® Meniscus Implant
- ClinicalTrials.gov ID
- NCT03953846
- Acronym / sponsor ID
- NIR / 01003
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Active Implants Europe closed operations
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Phoenix KineticsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 17 May 2019 (actual)
- 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 purpose of this active post-market surveillance clinical registry study is to further characterize the therapeutic effect, the long-term safety and effectiveness of the NUsurface® meniscus implant in the real-world post-marketing setting
Detailed description
Patients eligible for the Registry includes any patient who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria (Evidence of a personally signed and dated informed consent document). The NUsurface Implant Regitstry is about data collection only and under routine standard of care by treating physician. Data collection points are pre-op (i.e. baseline), surgery and multiple times after surgery during the first 6 months to correspond to clinic standard of care schedules, 6 months, 1 year post-operatively and then yearly thereafter out to 10 years.Surveys used are KOOS; Knee injury and Osteoarthritis Outcome Score \& WOMET; Western Ontario Meniscal Evaluation Tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population eligible for this protocol includes any subject who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria
Key inclusion criteria (2 listed)
- New or current treatment with the NUsurface® meniscus implant
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the Registry.
Key exclusion criteria (1 listed)
- There are no protocol exclusion criteria; all subjects who meet the inclusion criteria are eligible for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
KOOS (Knee Osteoarthritis Outcome Score) Pain improvement
Time frame: 24 months
a responder is defined as a patient with an increase of at least 20 points on the KOOS pain assessment
WOMET (Western Ontario Meniscus Evaluation Tool) score improvement
Time frame: 24 months
a responder is defined as a patient with an increase of at least 12 points on the WOMET assessment
Results and safety
The study was stopped early (reason given: Active Implants Europe closed operations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Meniscus; Degeneration
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Recruiting
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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.
Ryan Belaney, MSBME study director
Phoenix Kinetics
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus; Degeneration and Knee Osteoarthritis, run by Phoenix Kinetics at 6 sites in 4 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 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 6 sites in Germany, Belgium, Israel, Netherlands. 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 was stopped early (reason given: Active Implants Europe closed operations). Results are not available in the source record.
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 (Knee Osteoarthritis Outcome Score) Pain improvement (time frame: 24 months). 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?
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 9 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.