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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Cartilage Diseases

Intervention / Treatment
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* Device: MAC with NOVOCART Basic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of therapy change | Rate of therapy change (other surgical cartilage repair modality applied to the MAC treated defect(s)) | Up to 5 years | 
| Rate of adverse device effects | Number of treatment related adverse device effects | Up to 5 years | 
| Rate of device deficiencies | Number of device deficiencies | Up to 5 years | 
| Rate of adverse events related to the procedure involved | Number of adverse events related to the procedure involved | Up to 5 years | 
| KOOS | Questionnaire: Knee injury and Osteoarthrisits Outcome Score (KOOS)(KOOS5 and subscores) | Up to 5 years | 
| IKDC | Questionnaire: International Knee Documentation Committee (IKDC2000) subjective score | Up to 5 years | 
| EQ-5D-5L | Quality of life (EQ-5D-5L index) | Up to 5 years | 
| Patient satisfaction with treatment | 5 questions to patient satisfaction with treatment | Up to 5 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cartilage defect, knee, MAC (Matrix associated chondrogenesis)