NCT03808623

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

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: Tetec AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Cartilage Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-04-09
• Primary completion: 2019-07-24
• Completion: 2019-07-24
• First posted: 2019-01-17
• Last updated: 2020-04-02

Locations

3 sites across 2 countries: Germany, Switzerland