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

NCT ID: NCT03808623

Last Updated: 2020-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2019-07-24

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

MAC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aesculap AG

INDUSTRY

Sponsor Role: collaborator

Winicker Norimed GmbH

INDUSTRY

Sponsor Role: collaborator

Tetec AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernhard Waibl, MD

Role: PRINCIPAL_INVESTIGATOR

Cartilage Care

Locations

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Mannheim, Baden-Wurttemberg, Germany

Praxisklinik Rennbahn AG

Muttenz, Cantone of Basel-Landschaft, Switzerland

Cartilage Care

Bern, Cantone of Bern, Switzerland

Countries

Germany; Switzerland

Other Identifiers

AAG-O-H-1712

Identifier Type: -

Identifier Source: org_study_id