Non-interventional Study With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee With MAC
- Conditions
- Cartilage Diseases
- Registration Number
- NCT03808623
- Lead Sponsor
- Tetec AG
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the safety of NOVOCART® Basic Up to 5 years Number of participants with treatment related adverse device effects or adverse events related to the procedure involved
- Secondary Outcome Measures
Name Time Method Rate of therapy change Up to 5 years Rate of therapy change (other surgical cartilage repair modality applied to the MAC treated defect(s))
KOOS Up to 5 years Questionnaire: Knee injury and Osteoarthrisits Outcome Score (KOOS)(KOOS5 and subscores)
Rate of adverse device effects Up to 5 years Number of treatment related adverse device effects
Rate of device deficiencies Up to 5 years Number of device deficiencies
Rate of adverse events related to the procedure involved Up to 5 years Number of adverse events related to the procedure involved
IKDC Up to 5 years Questionnaire: International Knee Documentation Committee (IKDC2000) subjective score
EQ-5D-5L Up to 5 years Quality of life (EQ-5D-5L index)
Patient satisfaction with treatment Up to 5 years 5 questions to patient satisfaction with treatment
MRI if available Up to 5 years 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
Trial Locations
- Locations (3)
Praxisklinik Rennbahn AG
🇨🇭Muttenz, Cantone Of Basel-Landschaft, Switzerland
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
🇩🇪Mannheim, Baden-Württemberg, Germany
Cartilage Care
🇨🇭Bern, Cantone Of Bern, Switzerland