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

Cartilage Disease Clinical Trial

— NINJA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05391841
• Other study ID #: AAG-O-H-2123
• Status: Not yet recruiting
• Start date: May 31, 2024
• Est. completion date: May 2032

Study information

• Verified date: November 2023
• Source: Tetec AG
• Contact: Silvia Rombach, Dr.
• Phone: +49 7121 1626 202
• Email: silvia.rombach[@]tetec-ag.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2032
• Est. primary completion date: May 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cartilage Disease
• Cartilage Diseases

Intervention

Drug:
• NOVOCART Inject
Autologous Chondrocyte Implantation

Locations

Country	Name	City	State
Germany	St. Josefs-Hospital Cloppenburg gemeinnützige GmbH	Cloppenburg
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Klinikum rechts der Isar, Technische Universität München	München
Germany	OCM Klinik GmbH München	München
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Universitätsklinikum Tübingen	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
Tetec AG	Winicker Norimed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse reactions	Continuous assessment of adverse reactions (ARs)	24-months Follow up, 60-months Follow-up
Other	Number of device deficiencies - trephine	Number of device deficiencies - trephine	24-months Follow up, 60-months Follow-up
Other	Number of device deficiencies - Application System	Number of device deficiencies - Application System	24-months Follow up, 60-months Follow-up
Other	Number of device deficiencies - number of product related issues	Number of device deficiencies - number of product related issues	24-months Follow up, 60-months Follow-up
Primary	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.	24-months Follow-up
Secondary	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	24-months Follow-up
Secondary	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	24-months Follow-up
Secondary	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	24-months Follow-up
Secondary	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	24-months Follow-up
Secondary	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	24-months Follow-up
Secondary	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	24-months Follow-up
Secondary	Proportion of patients with treatment failure	Proportion of patients with treatment failure	24-months Follow up, 60-months Follow-up
Secondary	Number of postop physical therapy	Number of postop physical therapy	24-months Follow up, 60-months Follow-up
Secondary	Number of postop doctor visits	Number of postop doctor visits	24-months Follow up, 60-months Follow-up
Secondary	Days of hospitalisation	Days of hospitalisation	24-months Follow up, 60-months Follow-up
Secondary	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)	24-months Follow up, 60-months Follow-up
Secondary	Days of work/school missed	Days of work/school missed	24-months Follow up, 60-months Follow-up
Secondary	Patient satisfaction	Patient questionnaire, 4 questions with 3 answer choices better, same, worse	24-months Follow up, 60-months Follow-up
Secondary	Treatment-related adverse reactions (ARs)	Treatment-related adverse reactions (ARs)	24-months Follow up, 60-months Follow-up
Secondary	Rate of unplanned re-operations	Rate of unplanned re-operations: all unplanned reoperations and those related to NOVOCART® Inject treatment	24-months Follow up, 60-months Follow-up
Secondary	Surgical time	cut-to-suture time	24-months Follow up, 60-months Follow-up
Secondary	Length of incision	Length of incision	24-months Follow up, 60-months Follow-up