Clinical trial NCT04186208: Non-interventional Study With NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cartilage Disease
Keywords: cartilage defect
knee
pediatric patients
Lead sponsor: Tetec AG
Sponsor class: INDUSTRY
Collaborators: name: Aesculap AG
name: Winicker Norimed GmbH
First posted: 2019-12-04
Enrollment: 42
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion criteria:

• none

Primary outcomes:
measure: Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score)
timeFrame: 24 months Follow Up (FU)
Secondary outcomes:
measure: Change of 5 subscores KOOS
timeFrame: 24 months FU
measure: IKDC subjective
timeFrame: 24 month FU
measure: pain VAS
timeFrame: 24 month FU
measure: MOCART
timeFrame: 24 month FU
measure: KOOS responder rate
timeFrame: 24 month FU
measure: IKDC subjective responder rate
timeFrame: 24 months FU
measure: Proportion of patients with Treatment failures
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Health economics variable (Days of missing work/school ) to NOVOCART 3D treatment
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Health economics variable (Days of hospitalization ) to NOVOCART 3D treatment
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Health economics variable (Number of postoperative doctor visits) to NOVOCART 3D treatment
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Sportklinik Stuttgart
state: Baden Württemberg
city: Mannheim
country: Germany
facility: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
state: Baden-Württemberg
city: München
country: Germany
facility: Klinik und Poliklinik für Orthophädie, Physikalische Medizin und Rehabilitation Knie- und Schulterorthopädie
state: Bayern
city: München
country: Germany
facility: Klinikum rechts der Isar der technischen Universität München
state: Bayern
city: Regensburg
country: Germany
facility: Univerisätsklinikum Regensburg
state: Bayern
city: Kiel
country: Germany
facility: Lubinus Clinicum Kiel
state: Schleswig-Holstein
Study officials:
affiliation: Universitätsklinikum Regensburg
name: Peter Angele, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: