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Cartilage DiseaseNINJANCT05391841

Non-interventional Study in Pediatric Patients Treated With NOVOCART Inject in the Knee

An observational study of Cartilage Disease, run by Tetec AG at 6 sites in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® Inject in the treatment of cartilage defects of the knee in pediatric patients with radiologically proven closed epiphyseal growth plates. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Cartilage Disease
What is being tested?
NOVOCART Inject
How many people
0 participants
Where
6 sitesGermany
Study dates
May 2025to May 2032
How long will I take part?
5 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 Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: 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 osteochondrosis dissecans and who are scheduled for treatment with NOVOCART Inject SmPC, where the therapeutic indications, contraindications, special warnings and precautions for use are listed in detail. The decision to treat patients with NOVOCART Inject must be made independently from the patient's participation in the study.

Who may be able to join

  • Pediatric patients (< 18 years of age at implantation)
  • Closure of the epiphysis adjacent to the biopsy harvest site or the defect to be treated confirmed by an adequate imaging modality
  • Localized full-thickness cartilage defect (ICRS grade III or IV) of the knee
  • Medicinal indication for NOVOCART® Inject treatment

Who cannot join

  • see NOVOCART Inject SmPC

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • St. Josefs-Hospital Cloppenburg gemeinnützige GmbH

    Cloppenburg, 49661

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79119

  • OCM Klinik GmbH München

    München, 81369

  • Klinikum rechts der Isar, Technische Universität München

    München, 81675

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

About this study

Official title: Prospective, Non-interventional Study to Evaluate the Efficacy and Safety of NOVOCART Inject for the Treatment of Cartilage Defects in the Knee in Pediatric Patients With Closed Epiphyses

The study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® Inject in the treatment of cartilage defects of the knee in pediatric patients with radiologically proven closed epiphyseal growth plates.

Read the detailed description

In this non-interventional study NOVOCART® Inject, which is marketed in Germany under a license according to Section 4b of the AMG, will be used in routine clinical practice according to the current authorized Summary of Product Characteristics (SmPC). As stated in this SmPC, NOVOCART® Inject may only be used by physicians who are trained on the product. The treatment with NOVOCART® Inject requires two surgeries. During the first surgery cartilage tissue will be harvested arthroscopically and sent to TETEC AG for NOVOCART® Inject manufacturing, then NOVOCART® Inject will be transplanted during a second surgery about 3 to 4 weeks later.

All patients will be followed up for 5 years post NOVOCART® Inject implantation and data will be collected preoperatively and at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined at the end of this synopsis.

NOVOCART® Inject 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® Inject implantation (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 by TETEC AG.

Being tested
NOVOCART Inject
Keywords
NOVOCART Inject, Cartilage Defect, Pediatric Patients, Knee, Cartilage Injury
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 InjectDrug

    Autologous Chondrocyte Implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Responder rate of overall KOOS

    The overall Knee injury and Osteoarthritis Outcome Score (KOOS5) responder rate defined as the proportion of patients with ≥ 10 points improvement in the KOOS5 from baseline.

    Measured: 24-months Follow-up

Secondary outcomes (17)

  1. Change of overall KOOS from baseline

    Change of overall KOOS from baseline to the 24-month assessment, Knee Injury and Osteoarthritis Outcome Score, score 0-100, higher score shows better outcome

    Measured: 24-months Follow-up

  2. Change of the 5 sub-scores of the KOOS from baseline

    Change of the 5 sub-scores of the KOOS from baseline to the 24-month assessment, Knee Injury and Osteoarthritis Outcome Score, score 0-100, higher score shows better outcome

    Measured: 24-months Follow-up

  3. Change of the IKDC subjective score from baseline

    Change from baseline to the 24-month visit in the IKDC subjective score, international knee documentation committee, score 0-100, higher score shows better outcome

    Measured: 24-months Follow-up

  4. Change in the IKDC surgeon's part from baseline

    Change from baseline to the 24-month visit in the IKDC surgeon's part. international knee documentation committee, score 0-100, higher score shows better outcome

    Measured: 24-months Follow-up

  5. MOCART (MRI imaging)

    In vivo performance measured by the assessment of the Magnetic Resonance, Observation of Cartilage Repair Tissue (MOCART) score, Magnetic Resonance Observation of Cartilage Repair Tissue, score 0-100, higher score shows better outcome

    Measured: 24-months Follow-up

  6. IKDC subjective score responder rate

    IKDC subjective score responder rate, defined as the proportion of patients with > 20.5 points improvement in the IKDC subjective score from baseline to the 24-month visit

    Measured: 24-months Follow-up

  7. Proportion of patients with treatment failure

    Proportion of patients with treatment failure

    Measured: 24-months Follow up, 60-months Follow-up

  8. Number of postop physical therapy

    Number of postop physical therapy

    Measured: 24-months Follow up, 60-months Follow-up

  9. Number of postop doctor visits

    Number of postop doctor visits

    Measured: 24-months Follow up, 60-months Follow-up

  10. Days of hospitalisation

    Days of hospitalisation

    Measured: 24-months Follow up, 60-months Follow-up

  11. Work/school status checklist

    Work/school status, changes due to injury in work or school status (pupil, worker full or part time, not working, job seeking)

    Measured: 24-months Follow up, 60-months Follow-up

  12. Days of work/school missed

    Days of work/school missed

    Measured: 24-months Follow up, 60-months Follow-up

  13. Patient satisfaction

    Patient questionnaire, 4 questions with 3 answer choices better, same, worse

    Measured: 24-months Follow up, 60-months Follow-up

  14. Treatment-related adverse reactions (ARs)

    Treatment-related adverse reactions (ARs)

    Measured: 24-months Follow up, 60-months Follow-up

  15. Rate of unplanned re-operations

    Rate of unplanned re-operations: all unplanned reoperations and those related to NOVOCART® Inject treatment

    Measured: 24-months Follow up, 60-months Follow-up

  16. Surgical time

    cut-to-suture time

    Measured: 24-months Follow up, 60-months Follow-up

  17. Length of incision

    Length of incision

    Measured: 24-months Follow up, 60-months Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2022
  2. Study startMay 2025 (estimated)
  3. Primary completionMay 2029 (estimated)
  4. Study completionMay 2032 (estimated)

Why it stopped: A waiver was granted for paediatric patients. Therefore, the study is not necessary.

Resources

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
0 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05391841
Sponsor's protocol ID
AAG-O-H-2123
Acronym
NINJA
Status last verified
May 2025
First submitted
8 Apr 2022
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 4 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: withdrawn, as of the sponsor's last update on 19 Sep 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Responder rate of overall KOOS (time frame: 24-months Follow-up). 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 NCT05391841.

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 19 Sep 2025.

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