Cartilage DiseasesNISANIKNCT02348697
Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects
An observational study of Cartilage Diseases, run by Tetec AG at 9 sites in Germany.
Trial summary
Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and adolescent patients with full thickness cartilage defects after the treatment with NOVOCART 3D. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Cartilage Diseases
- What is being tested?
- NOVOCART 3D
- How many people
- 81 participants
- Where
- 9 sitesGermany
- Study dates
- Jun 2015to 30 Oct 2019
- 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 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: specialist clinical centre
Who may be able to join
- Male and female adult patients
- Children and adolescents with closed epiphysial plate
- Defect size ≥2.5 and ≤10 cm2 post-debridement
- Localized full thickness articular cartilage defect of the knee (Grade 3 \& 4 International Cartilage Repair Society (ICRS) classification)
Who cannot join
- Radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade >2
- More than 2 defects or 2 corresponding lesions
- Ankylosis
- Arthrofibrosis
- Diffuse chondromalacia
- Total/subtotal resected meniscus
Show all 16Show fewer
- Insufficient Ligament guidance
- Patella malignement
- Inflammatory joint disease
- General cartilage degeneration or increased joint deterioration
- Cancer, present or within the last 5 years
- Primary treatment in children and adolescents with open epiphysial plate
- Chronical infection diseases
- Untreated coagulation disorder
- Pregnancy and lactating
- Known history of allergies against ingredients of NOVOCART® 3D
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Sozialstiftung Bamberg, Klinikum am Bruderwald
Bamberg, 98049
Gelenk Klinik Orthopaedic Clinic
Gundelfingen, 79194
Diakoniekrankenhaus Henriettenstiftung gGmbH
Hanover, 30171
Heidelberg University Hospital
Heidelberg, 69118
Lubinus Clinicum
Kiel, 24106
Theresienkrankenhaus
Mannheim, 68165
Klinik rechts der Isar
München, 81675
Department of Orthopedic Surgery and the Department of Physical Medicine and Rehabilitation LMU Munich
Munich, 81377
University Hospital Regensburg
Regensburg, 93053
About this study
Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and adolescent patients with full thickness cartilage defects after the treatment with NOVOCART 3D.
Read the detailed description
A 36-month post treatment follow up of adverse and serious adverse effects as well as the measurement of efficacy with the International Knee Documentation Committee (IKDC) Score.
- Conditions
- Cartilage Diseases
- Being tested
- NOVOCART 3D
- Keywords
- Cartilage Defect in the Knee, MACT
- Medical subject headings
- Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVOCART 3DBiological
Autologous Chondrocyte Implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
Measured: 36 month
Secondary outcomes (1)
Efficacy - International Knee Documentation Committee (IKDC) 2000
International Knee Documentation Committee (IKDC) 2000
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJun 2015
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DiseasesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aesculap AG
- Responsible party
- Sponsor
- Investigators
- Alexandra Kirner, PhD, Study director, TETEC AG Reutlingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348697
- Sponsor's protocol ID
- AAG-O-H-1418
- Other IDs
- 2015-000166-62, 2015
- Acronym
- NISANIK
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2015
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects
- ClinicalTrials.gov ID
- NCT02348697
- Acronym / sponsor ID
- NISANIK / AAG-O-H-1418
- Conditions
- Cartilage Diseases
- Keywords
- Cartilage Defect in the Knee, MACT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Tetec AGIndustry (pharma, biotech, devices)
- Collaborators
- Aesculap AG
- Study start
- Jun 2015 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 28 Jan 2015 (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.
Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and adolescent patients with full thickness cartilage defects after the treatment with NOVOCART 3D.
Detailed description
A 36-month post treatment follow up of adverse and serious adverse effects as well as the measurement of efficacy with the International Knee Documentation Committee (IKDC) Score.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- specialist clinical centre
Key inclusion criteria (4 listed)
- Male and female adult patients
- Children and adolescents with closed epiphysial plate
- Defect size ≥2.5 and ≤10 cm2 post-debridement
- Localized full thickness articular cartilage defect of the knee (Grade 3 \& 4 International Cartilage Repair Society (ICRS) classification)
Key exclusion criteria (16 listed)
- Radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade >2
- More than 2 defects or 2 corresponding lesions
- Ankylosis
- Arthrofibrosis
- Diffuse chondromalacia
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 |
|---|---|---|
| NOVOCART 3DAutologous Chondrocyte Implantation | Biological | – |
Primary outcome
Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
Time frame: 36 month
Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
1 secondary outcome
Efficacy - International Knee Documentation Committee (IKDC) 2000
Time frame: 36 month
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 3 Dec 2019.
- 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.
Alexandra Kirner, PhD study director
TETEC AG Reutlingen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Diseases, run by Tetec AG at 9 sites in Germany.
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 4 inclusion and 16 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 3 Dec 2019. 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 Germany. 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?
Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety (time frame: 36 month). 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 3 Dec 2019.