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

Cartilage Disease Clinical Trial

— JUNOVO  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04186208
• Other study ID #: AAG-O-H-1633
• Status: Active, not recruiting
• Start date: April 25, 2017
• Est. completion date: June 2026

Study information

• Verified date: November 2023
• Source: Tetec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: June 2026
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• 13 - 17 years old

• Medicinal indication for NOVOCART 3D treatment

Exclusion criteria:

• none

Related Conditions & MeSH terms

• Cartilage Disease
• Cartilage Diseases

Intervention

Drug:
• NOVOCART 3D
Autologous Chondrocyte Implantation

Locations

Country	Name	City	State
Germany	Lubinus Clinicum Kiel	Kiel	Schleswig-Holstein
Germany	Theresienkrankenhaus und St. Hedwig-Klinik GmbH	Mannheim	Baden-Württemberg
Germany	Klinik und Poliklinik für Orthophädie, Physikalische Medizin und Rehabilitation Knie- und Schulterorthopädie	München	Bayern
Germany	Klinikum rechts der Isar der technischen Universität München	München	Bayern
Germany	Univerisätsklinikum Regensburg	Regensburg	Bayern
Germany	Sportklinik Stuttgart	Stuttgart	Baden Württemberg

Sponsors (3)

Lead Sponsor	Collaborator
Tetec AG	Aesculap AG, Winicker Norimed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score)	Change of KOOS defined as the average of the 5 subscale scores (range 0-100, higher values represent a better outcome)	24 months Follow Up (FU)
Secondary	Change of 5 subscores KOOS	Change of the 5 subscores of KOOS (range 0-100, higher values represent a better outcome)	24 months FU
Secondary	IKDC subjective	Change of IKDC (International Knee Documentation Committee) subjective (range 0-100, higher values represent a better outcome)	24 month FU
Secondary	pain VAS	Change in pain VAS (Visual Analogue Scale) (range 0-10, higher values represent a better outcome)	24 month FU
Secondary	MOCART	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)	24 month FU
Secondary	KOOS responder rate	KOOS responder rate defined as Proportion of patients with > 10 Points improvement in KOOS	24 month FU
Secondary	IKDC subjective responder rate	IKDC subjective responder rate defined as Proportion of patients with >20.5 Points improvement in IKDC subjective	24 months FU
Secondary	Proportion of patients with Treatment failures	Proportion of patients with Treatment failures	3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Secondary	Health economics variable (Days of missing work/school ) to NOVOCART 3D treatment	Days of missing work/school due to knee pain/function issues in the target knee	3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Secondary	Health economics variable (Days of hospitalization ) to NOVOCART 3D treatment	Days of hospitalization due to knee pain/function issues in the target knee	3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Secondary	Health economics variable (Number of postoperative doctor visits) to NOVOCART 3D treatment	Number of postoperative doctor visits	3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months