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

NCT05391841 | Withdrawn

• 1 other identifier: AAG-O-H-2123
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Cartilage Disease

Keywords

NOVOCART Inject; Cartilage Defect; Pediatric Patients; Knee; Cartilage Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Change of overall KOOS from baseline

  24-months Follow-up

• Change of the 5 sub-scores of the KOOS from baseline

  24-months Follow-up

• Change of the IKDC subjective score from baseline

  24-months Follow-up

• Change in the IKDC surgeon's part from baseline

  24-months Follow-up

• MOCART (MRI imaging)

  24-months Follow-up

Other Outcomes (4)

• Adverse reactions

  24-months Follow up, 60-months Follow-up

• Number of device deficiencies - trephine

  24-months Follow up, 60-months Follow-up

• Number of device deficiencies - Application System

  24-months Follow up, 60-months Follow-up

Interventions

NOVOCART Inject DRUG

Autologous Chondrocyte Implantation

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• see NOVOCART Inject SmPC

Sponsors & Collaborators

• Tetec AG: lead
• Winicker Norimed GmbH: collaborator

Study Sites (6)

St. Josefs-Hospital Cloppenburg gemeinnützige GmbH

Cloppenburg, 49661, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79119, Germany

Location

OCM Klinik GmbH München

München, 81369, Germany

Location

Klinikum rechts der Isar, Technische Universität München

München, 81675, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Cartilage Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter Angele, Prof. Dr.

  Universitätsklinik Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: May 26, 2022
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2032
• Last Updated: September 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)