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NCT Number: NCT04186208

Non-interventional Study With NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients

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.

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Key information

Conditions

Cartilage Disease Cartilage Diseases Connective Tissue Diseases Musculoskeletal Diseases Skin and Connective Tissue Diseases

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Theresienkrankenhaus und St. Hedwig-Klinik GmbH, Mannheim, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 13 - 17 years old
  • Medicinal indication for NOVOCART 3D treatment

Exclusion criteria

  • none

Treatment and study plan

NOVOCART 3D

Drug

Autologous Chondrocyte Implantation

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change of 5 subscores KOOS

    Time frame: 24 months FU

    Change of the 5 subscores of KOOS (range 0-100, higher values represent a better outcome)

  2. IKDC subjective

    Time frame: 24 month FU

    Change of IKDC (International Knee Documentation Committee) subjective (range 0-100, higher values represent a better outcome)

  3. pain VAS

    Time frame: 24 month FU

    Change in pain VAS (Visual Analogue Scale) (range 0-10, higher values represent a better outcome)

  4. MOCART

    Time frame: 24 month FU

    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)

  5. KOOS responder rate

    Time frame: 24 month FU

    KOOS responder rate defined as Proportion of patients with > 10 Points improvement in KOOS

  6. IKDC subjective responder rate

    Time frame: 24 months FU

    IKDC subjective responder rate defined as Proportion of patients with >20.5 Points improvement in IKDC subjective

  7. Proportion of patients with Treatment failures

    Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

    Proportion of patients with Treatment failures

  8. 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

    Days of missing work/school due to knee pain/function issues in the target knee

  9. 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

    Days of hospitalization due to knee pain/function issues in the target knee

  10. 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

    Number of postoperative doctor visits

Sponsors and collaborators

Lead sponsor

Tetec AG

Industry

Collaborators

  • Aesculap AG
  • Winicker Norimed GmbH

Registry information

Official study 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

Acronym: JUNOVO

Important dates

Study start
2017
Primary completion
2023
Study completion
2026
First posted
Dec 4, 2019
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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