Clinical trial NCT05391841: Non-interventional Study in Pediatric Patients Treated With NOVOCART Inject in the Knee
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
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Cartilage Disease
Keywords: NOVOCART Inject
Cartilage Defect
Pediatric Patients
Knee
Cartilage Injury
Lead sponsor: Tetec AG
Sponsor class: INDUSTRY
Collaborators: name: Winicker Norimed GmbH
First posted: 2022-05-26
Enrollment: 30
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

see NOVOCART Inject SmPC

Primary outcomes:
measure: Responder rate of overall KOOS
timeFrame: 24-months Follow-up
Secondary outcomes:
measure: Change of overall KOOS from baseline
timeFrame: 24-months Follow-up
measure: Change of the 5 sub-scores of the KOOS from baseline
timeFrame: 24-months Follow-up
measure: Change of the IKDC subjective score from baseline
timeFrame: 24-months Follow-up
measure: Change in the IKDC surgeon's part from baseline
timeFrame: 24-months Follow-up
measure: MOCART (MRI imaging)
timeFrame: 24-months Follow-up
measure: IKDC subjective score responder rate
timeFrame: 24-months Follow-up
measure: Proportion of patients with treatment failure
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Number of postop physical therapy
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Number of postop doctor visits
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Days of hospitalisation
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Work/school status checklist
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Days of work/school missed
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Patient satisfaction
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Treatment-related adverse reactions (ARs)
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Rate of unplanned re-operations
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Surgical time
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Length of incision
timeFrame: 24-months Follow up, 60-months Follow-up
Other outcomes:
measure: Adverse reactions
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Number of device deficiencies - trephine
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Number of device deficiencies - Application System
timeFrame: 24-months Follow up, 60-months Follow-up
measure: Number of device deficiencies - number of product related issues
timeFrame: 24-months Follow up, 60-months Follow-up
Locations:
city: Cloppenburg
country: Germany
facility: St. Josefs-Hospital Cloppenburg gemeinnützige GmbH
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: München
country: Germany
facility: OCM Klinik GmbH München
city: München
country: Germany
facility: Klinikum rechts der Isar, Technische Universität München
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
Study officials:
affiliation: Universitätsklinik Regensburg
name: Peter Angele, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: