Clinical trial NCT03808623: Non-interventional Study With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee With MAC
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cartilage Diseases
Keywords: cartilage defect
knee
MAC (Matrix associated chondrogenesis)
Lead sponsor: Tetec AG
Sponsor class: INDUSTRY
Collaborators: name: Aesculap AG
name: Winicker Norimed GmbH
First posted: 2019-01-17
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: Assessment of the safety of NOVOCART® Basic
timeFrame: Up to 5 years
Secondary outcomes:
measure: Rate of therapy change
timeFrame: Up to 5 years
measure: Rate of adverse device effects
timeFrame: Up to 5 years
measure: Rate of device deficiencies
timeFrame: Up to 5 years
measure: Rate of adverse events related to the procedure involved
timeFrame: Up to 5 years
measure: KOOS
timeFrame: Up to 5 years
measure: IKDC
timeFrame: Up to 5 years
measure: EQ-5D-5L
timeFrame: Up to 5 years
measure: Patient satisfaction with treatment
timeFrame: Up to 5 years
measure: MRI if available
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
state: Baden-Württemberg
city: Muttenz
country: Switzerland
facility: Praxisklinik Rennbahn AG
state: Cantone Of Basel-Landschaft
city: Bern
country: Switzerland
facility: Cartilage Care
state: Cantone Of Bern
Study officials:
affiliation: Cartilage Care
name: Bernhard Waibl, MD
role: PRINCIPAL_INVESTIGATOR
References: