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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cartilage Disease
• Intervention / Treatment: Drug: NOVOCART 3D

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.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Germany
  • Baden Württemberg
    • Stuttgart, Baden Württemberg, Germany, 70372
      • Sportklinik Stuttgart
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68165
      • Theresienkrankenhaus und St. Hedwig-Klinik GmbH
  • Bayern
    • München, Bayern, Germany, 81675
      • Klinikum Rechts Der Isar Der Technischen Universität München
    • München, Bayern, Germany, 81377
      • Klinik und Poliklinik für Orthophädie, Physikalische Medizin und Rehabilitation Knie- und Schulterorthopädie
    • Regensburg, Bayern, Germany, 93047
      • Univerisätsklinikum Regensburg
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24106
      • Lubinus Clinicum Kiel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of 5 subscores KOOS	Change of the 5 subscores of KOOS (range 0-100, higher values represent a better outcome)	24 months FU
IKDC subjective	Change of IKDC (International Knee Documentation Committee) subjective (range 0-100, higher values represent a better outcome)	24 month FU
pain VAS	Change in pain VAS (Visual Analogue Scale) (range 0-10, higher values represent a better outcome)	24 month FU
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
KOOS responder rate	KOOS responder rate defined as Proportion of patients with > 10 Points improvement in KOOS	24 month FU
IKDC subjective responder rate	IKDC subjective responder rate defined as Proportion of patients with >20.5 Points improvement in IKDC subjective	24 months FU
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
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
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
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

Collaborators and Investigators

• Sponsor: Tetec AG
• Collaborators: Winicker Norimed GmbH; Aesculap AG
• Investigators: Principal Investigator: Peter Angele, Prof. MD, Universitätsklinikum Regensburg

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: knee; pediatric patients; cartilage defect
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: AAG-O-H-1633

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No