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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cartilage Disease
• Intervention / Treatment: Drug: NOVOCART Inject

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Silvia Rombach, Dr.; Phone Number: +49 7121 1626 202; Email: silvia.rombach@tetec-ag.de

Study Locations

• Germany
  • Cloppenburg, Germany, 49661
    • St. Josefs-Hospital Cloppenburg gemeinnützige GmbH
    • Contact: Boris Baron von Engelhardt, Dr. med.; Phone Number: +494471 16 2008; Email: boris.vonEngelhardt@kh-clp.de
  • Freiburg, Germany, 79119
    • Universitätsklinikum Freiburg
    • Contact: Hagen Schmal, Prof. Dr.; Phone Number: +49 761 270-26990; Email: hagen.schmal@uniklinik-freiburg.de
  • München, Germany, 81369
    • OCM Klinik GmbH München
    • Contact: Phillipp Niemeyer, Prof. Dr.; Phone Number: +49 89 206082-0; Email: philipp.niemeyer@ocm-muenchen.de
  • München, Germany, 81675
    • Klinikum rechts der Isar, Technische Universität München
    • Contact: Sebastian Siebenlist, Prof. Dr.; Phone Number: +49(0)89 41405118; Email: sebastian.siebenlist@mri.tum.de
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg
    • Contact: Peter Angele, Prof. Dr.; Phone Number: 0941 944-6805; Email: peter.angele@ukr.de
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
    • Contact: Christian Konrads, PD Dr.; Phone Number: +49 7071 29-68217; Email: Christian.Konrads@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

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

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Proportion of patients with treatment failure	Proportion of patients with treatment failure	24-months Follow up, 60-months Follow-up
Number of postop physical therapy	Number of postop physical therapy	24-months Follow up, 60-months Follow-up
Number of postop doctor visits	Number of postop doctor visits	24-months Follow up, 60-months Follow-up
Days of hospitalisation	Days of hospitalisation	24-months Follow up, 60-months Follow-up
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
Days of work/school missed	Days of work/school missed	24-months Follow up, 60-months Follow-up
Patient satisfaction	Patient questionnaire, 4 questions with 3 answer choices better, same, worse	24-months Follow up, 60-months Follow-up
Treatment-related adverse reactions (ARs)	Treatment-related adverse reactions (ARs)	24-months Follow up, 60-months Follow-up
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
Surgical time	cut-to-suture time	24-months Follow up, 60-months Follow-up
Length of incision	Length of incision	24-months Follow up, 60-months Follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions	Continuous assessment of adverse reactions (ARs)	24-months Follow up, 60-months Follow-up
Number of device deficiencies - trephine	Number of device deficiencies - trephine	24-months Follow up, 60-months Follow-up
Number of device deficiencies - Application System	Number of device deficiencies - Application System	24-months Follow up, 60-months Follow-up
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

Collaborators and Investigators

• Sponsor: Tetec AG
• Collaborators: Winicker Norimed GmbH
• Investigators: Principal Investigator: Peter Angele, Prof. Dr., Universitätsklinik Regensburg

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): August 1, 2027
• Study Completion (Anticipated): July 1, 2030

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Knee; Pediatric Patients; NOVOCART Inject; Cartilage Defect; Cartilage Injury
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: AAG-O-H-2123

Drug and device information, study documents

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