Non-interventional Study With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee With MAC

Cartilage Diseases Clinical Trial

— NBasic  

Official title:

Non-interventional Study to Evaluate the Safety and Performance of NOVOCART® Basic and the Clinical Outcome of MAC With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808623
• Other study ID #: AAG-O-H-1712
• Status: Completed
• Start date: April 9, 2018
• Est. completion date: July 24, 2019

Study information

• Verified date: March 2020
• Source: Tetec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective, multicenter, single arm, non-interventional study to assess the safety and Performance of NOVOCART Basic and the clinical outcome of MAC with NOVOCART Basic in patients treated for cartilage defects in the knee.

Description:

This study is a multi-center, single arm, non-interventional study to assess the safety and performance of NOVOCART® Basic and the clinical outcome of MAC with NOVOCART® Basic in patients treated for cartilage defects in the knee. In this study data will be collected retrospectively from patient files of adult and pediatric patients who had received an MAC with NOVOCART® Basic for cartilage defects in the knee according to medical practice. In addition, at the time when a patient consents to participate in the study, he/she will have to fill-out questionnaires on current symptoms and knee function, quality of life, satisfaction with treatment and subsequent surgical interventions on the target knee performed outside the study site, i.e. the duration of follow-up is not standardized. All clinical sites having treated more than 8 patients with NOVOCART® Basic between 2014 and 2017 will be contacted for participation. Participating clinical sites will be asked to collect informed consent from their patients to document relevant data from their medical charts and to complete the questionnaires. Consenting patients will send the signed informed consent form(s) and the completed questionnaires back to the study site. The date of questionnaire completion is regarded the end of observation for an individual patient. For data documentation, a medical documentation specialist authorized by TETEC AG will be given access to the patient files, the informed consent forms, and the completed questionnaires. The relevant data will be entered directly into an electronic database by the medical documentation specialist. Only data from patients who have given informed consent to study participation will be documented. If available, post-MAC MRIs will be collected and reviewed by independent experts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 24, 2019
• Est. primary completion date: July 24, 2019
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• for the biological reconstruction of localized full-layer cartilage damage (III and IV degree defects pursuant to the ICRS classification) in the knee joint.

• Treatable defects include:

• Cartilage damage caused by trauma

• Defects due to osteochondrosis dissecans

• Smaller focally-limited, degenerative cartilage damage

• Patients aged between 18 and 55 years

• Cartilage defect sizes from 1.5 to 4 cm²

• Deep osseous substance defects require prior osseous reconstruction. The indication should be confirmed using arthroscopy.

Exclusion Criteria:

• Patients with known allergies to bovine collagen.

• Infected joints or infected wounds/areas near the joint, arthritis or inflammatory joint diseases of any type are contraindicated.

• More than two corresponding cartilage defects

• Instability of the knee, subtotal/total meniscus resection

• Varus/valgus malpositions (corrective surgery required in such cases)

• Haemorrhagic diathesis of various origins

• Applications which are not listed in the Indications section.

Related Conditions & MeSH terms

• Cartilage Diseases

Intervention

Device:
• MAC with NOVOCART Basic
NOVOCART® Basic is a biphasic, collagen-based matrix to support the biological reconstruction of localized and full-thickness cartilage damages after treatment with bone marrow stimulation techniques (microfracture). The procedure is called matrix associated chondrogenesis (MAC). It is a single-step procedure. NOVOCART® Basic is tailored to fit the prepared defect size and is inserted in the defect area after microfracture. The NOVOCART® Basic device component is fully resorbed over a period of a few months as new reparative cartilage tissue is generated and integrated with the surrounding host tissue.

Locations

Country	Name	City	State
Germany	Theresienkrankenhaus und St. Hedwig-Klinik GmbH	Mannheim	Baden-Württemberg
Switzerland	Cartilage Care	Bern	Cantone Of Bern
Switzerland	Praxisklinik Rennbahn AG	Muttenz	Cantone Of Basel-Landschaft

Sponsors (3)

Lead Sponsor	Collaborator
Tetec AG	Aesculap AG, Winicker Norimed GmbH

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the safety of NOVOCART® Basic	Number of participants with treatment related adverse device effects or adverse events related to the procedure involved	Up to 5 years
Secondary	Rate of therapy change	Rate of therapy change (other surgical cartilage repair modality applied to the MAC treated defect(s))	Up to 5 years
Secondary	Rate of adverse device effects	Number of treatment related adverse device effects	Up to 5 years
Secondary	Rate of device deficiencies	Number of device deficiencies	Up to 5 years
Secondary	Rate of adverse events related to the procedure involved	Number of adverse events related to the procedure involved	Up to 5 years
Secondary	KOOS	Questionnaire: Knee injury and Osteoarthrisits Outcome Score (KOOS)(KOOS5 and subscores)	Up to 5 years
Secondary	IKDC	Questionnaire: International Knee Documentation Committee (IKDC2000) subjective score	Up to 5 years
Secondary	EQ-5D-5L	Quality of life (EQ-5D-5L index)	Up to 5 years
Secondary	Patient satisfaction with treatment	5 questions to patient satisfaction with treatment	Up to 5 years
Secondary	MRI if available	Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score will be used for assessment of the in vivo performance, if post-MAC MRIs are available from clinical routine	Up to 5 years