NCT04186208

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Tetec AG · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cartilage Disease

Interventions

Type	Name	Description
DRUG	NOVOCART 3D	Autologous Chondrocyte Implantation

Timeline

• Start date: 2017-04-25
• Primary completion: 2023-06-14
• Completion: 2026-06-01
• First posted: 2019-12-04
• Last updated: 2025-05-14

Locations

6 sites across 1 country: Germany