Cartilage DiseaseJUNOVONCT04186208
Non-interventional Study With NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients
An observational study of Cartilage Disease, run by Tetec AG at 6 sites in Germany.
Trial summary
Prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART 3D in the Treatment fo cartilage defects of the knee in pediatric patients wieh closed epiphyseal growth plates. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Cartilage Disease
- What is being tested?
- NOVOCART 3D
- How many people
- 42 participants
- Where
- 6 sitesGermany
- Study dates
- 25 Apr 2017to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will include pediatric patients (< 18 years of age) with closed epiphyses who suffer from a full-thickness cartilage defect of the knee caused by acute or repetitive trauma or by osteochondritis dissecans and who are scheduled for treatment with NOVOCART® 3D. Further inclusion/exclusion criteria are given in the current version of the NOVOCART® 3D SmPC, where the therapeutic indications, contraindications, special warnings and precautions for use are listed in detail. The decision to treat patients with NOVOCART® 3D must be made independently from the patient's participation in the study.
Who may be able to join
- 13 - 17 years old
- Medicinal indication for NOVOCART 3D treatment
Who cannot join
- none
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Lubinus Clinicum Kiel
Kiel, Schleswig-Holstein, 24106
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Mannheim, Baden-Wurttemberg, 68165
Klinik und Poliklinik für Orthophädie, Physikalische Medizin und Rehabilitation Knie- und Schulterorthopädie
München, Bavaria, 81377
Klinikum rechts der Isar der technischen Universität München
München, Bavaria, 81675
Univerisätsklinikum Regensburg
Regensburg, Bavaria, 93047
Sportklinik Stuttgart
Stuttgart, Baden-Wurttemberg, 70372
About this study
Official title: Prospective, Non-interventional Study to Evaluate the Efficacy and Safety of NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients With Closed Epiphyses
Prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART 3D in the Treatment fo cartilage defects of the knee in pediatric patients wieh closed epiphyseal growth plates.
Read the detailed description
The present study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® 3D in the treatment of cartilage defects of the knee in pediatric patients with closed epiphyseal growth plates.
In this non-interventional study NOVOCART® 3D, which is marketed in Germany under Paragraph 4b Medicinal Products Act, will be used in routine clinical practice according to the authorized Summary of Product Characteristics (SmPC). As stated in this SmPC, NOVOCART® 3D may only be used by physicians who are trained on the product. The treatment with NOVOCART® 3D requires two surgeries. During the first surgery cartilage biopsies will be harvested arthroscopically and sent to TETEC AG (Tissue Engineering Technologies AG) for NOVOCART® 3D manufacturing, then NOVOCART® 3D will be transplanted during a second surgery about 3 to 4 weeks later.
All patients will be followed up for 5 years post NOVOCART® 3D transplantation and data will be collected at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined at the end of this synopsis.
NOVOCART® 3D post treatment rehabilitation should follow the recommendations given in the SmPC and during product training.
The primary and secondary variables (see below) will be assessed after a follow-up of 24 month post NOVOCART® 3D transplantation (primary analysis).
Long-term data will be assessed after an additional 3 years follow-up (follow-up analysis).
The collected data will be documented using dedicated case report forms (CRFs) which are created and printed by TETEC AG.
- Conditions
- Cartilage Disease
- Being tested
- NOVOCART 3D
- Keywords
- cartilage defect, knee, pediatric patients
- 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 3DDrug
Autologous Chondrocyte Implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score)
Change of KOOS defined as the average of the 5 subscale scores (range 0-100, higher values represent a better outcome)
Measured: 24 months Follow Up (FU)
Secondary outcomes (10)
Change of 5 subscores KOOS
Change of the 5 subscores of KOOS (range 0-100, higher values represent a better outcome)
Measured: 24 months FU
IKDC subjective
Change of IKDC (International Knee Documentation Committee) subjective (range 0-100, higher values represent a better outcome)
Measured: 24 month FU
pain VAS
Change in pain VAS (Visual Analogue Scale) (range 0-10, higher values represent a better outcome)
Measured: 24 month FU
MOCART
In vivo Performance via MRI (Magnetic Resonance Imaging), MOCART Score (Magnetic Resonance Observation of Cartilage Repair Tissue) (range 0-100, higher values represent a better outcome)
Measured: 24 month FU
KOOS responder rate
KOOS responder rate defined as Proportion of patients with > 10 Points improvement in KOOS
Measured: 24 month FU
IKDC subjective responder rate
IKDC subjective responder rate defined as Proportion of patients with >20.5 Points improvement in IKDC subjective
Measured: 24 months FU
Proportion of patients with Treatment failures
Proportion of patients with Treatment failures
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Health economics variable (Days of missing work/school ) to NOVOCART 3D treatment
Days of missing work/school due to knee pain/function issues in the target knee
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Health economics variable (Days of hospitalization ) to NOVOCART 3D treatment
Days of hospitalization due to knee pain/function issues in the target knee
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Health economics variable (Number of postoperative doctor visits) to NOVOCART 3D treatment
Number of postoperative doctor visits
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start25 Apr 2017
- Primary completion14 Jun 2023
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DiseaseStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aesculap AG, Winicker Norimed GmbH
- Responsible party
- Sponsor
- Investigators
- Peter Angele, Prof. MD, Principal investigator, Universitätsklinikum Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186208
- Sponsor's protocol ID
- AAG-O-H-1633
- Acronym
- JUNOVO
- Status last verified
- May 2025
- First submitted
- 7 Jan 2019
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-interventional Study to Evaluate the Efficacy and Safety of NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients With Closed Epiphyses
- ClinicalTrials.gov ID
- NCT04186208
- Acronym / sponsor ID
- JUNOVO / AAG-O-H-1633
- Conditions
- Cartilage Disease
- Keywords
- cartilage defect, knee, pediatric patients
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tetec AGIndustry (pharma, biotech, devices)
- Collaborators
- Aesculap AG, Winicker Norimed GmbH
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 Dec 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.
Prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART 3D in the Treatment fo cartilage defects of the knee in pediatric patients wieh closed epiphyseal growth plates.
Detailed description
The present study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® 3D in the treatment of cartilage defects of the knee in pediatric patients with closed epiphyseal growth plates.
In this non-interventional study NOVOCART® 3D, which is marketed in Germany under Paragraph 4b Medicinal Products Act, will be used in routine clinical practice according to the authorized Summary of Product Characteristics (SmPC). As stated in this SmPC, NOVOCART® 3D may only be used by physicians who are trained on the product. The treatment with NOVOCART® 3D requires two surgeries. During the first surgery cartilage biopsies will be harvested arthroscopically and sent to TETEC AG (Tissue Engineering Technologies AG) for NOVOCART® 3D manufacturing, then NOVOCART® 3D will be transplanted during a second surgery about 3 to 4 weeks later.
All patients will be followed up for 5 years post NOVOCART® 3D transplantation and data will be collected at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined at the end of this synopsis.
NOVOCART® 3D post treatment rehabilitation should follow the recommendations given in the SmPC and during product training.
The primary and secondary variables (see below) will be assessed after a follow-up of 24 month post NOVOCART® 3D transplantation (primary analysis).
Long-term data will be assessed after an additional 3 years follow-up (follow-up analysis).
The collected data will be documented using dedicated case report forms (CRFs) which are created and printed by TETEC AG.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will include pediatric patients (< 18 years of age) with closed epiphyses who suffer from a full-thickness cartilage defect of the knee caused by acute or repetitive trauma or by osteochondritis dissecans and who are scheduled for treatment with NOVOCART® 3D. Further inclusion/exclusion criteria are given in the current version of the NOVOCART® 3D SmPC, where the therapeutic indications, contraindications, special warnings and precautions for use are listed in detail. The decision to treat patients with NOVOCART® 3D must be made independently from the patient's participation in the study.
Key inclusion criteria (2 listed)
- 13 - 17 years old
- Medicinal indication for NOVOCART 3D treatment
Key exclusion criteria (1 listed)
- none
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 | Drug | – |
Primary outcome
Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time frame: 24 months Follow Up (FU)
Change of KOOS defined as the average of the 5 subscale scores (range 0-100, higher values represent a better outcome)
10 secondary outcomes
Change of 5 subscores KOOS
Time frame: 24 months FU
IKDC subjective
Time frame: 24 month FU
pain VAS
Time frame: 24 month FU
MOCART
Time frame: 24 month FU
KOOS responder rate
Time frame: 24 month FU
IKDC subjective responder rate
Time frame: 24 months FU
Proportion of patients with Treatment failures
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Health economics variable (Days of missing work/school ) to NOVOCART 3D treatment
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Health economics variable (Days of hospitalization ) to NOVOCART 3D treatment
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Health economics variable (Number of postoperative doctor visits) to NOVOCART 3D treatment
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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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.
Peter Angele, Prof. MD principal investigator
Universitätsklinikum Regensburg
6 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 Disease, run by Tetec AG at 6 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 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score) (time frame: 24 months Follow Up (FU)). 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 14 May 2025.