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| Name | Class |
|---|---|
| Aesculap AG | INDUSTRY |
| Winicker Norimed GmbH | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAC with NOVOCART Basic | Device | 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients (adult and pediatric) who have received an MAC with NOVOCART® Basic in the knee are eligible for this study, provided that they have given their informed consent for data collection and the involved clinical site has agreed to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard Waibl, MD | Cartilage Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theresienkrankenhaus und St. Hedwig-Klinik GmbH | Mannheim | Baden-Wurttemberg | 68165 | Germany | ||
| Praxisklinik Rennbahn AG |
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| ID | Term |
|---|---|
| D002357 | Cartilage Diseases |
| D015270 | Mycobacterium avium-intracellulare Infection |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009165 | Mycobacterium Infections, Nontuberculous |
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| 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 |
| Muttenz |
| Cantone of Basel-Landschaft |
| 4132 |
| Switzerland |
| Cartilage Care | Bern | Cantone of Bern | 3012 | Switzerland |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |