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

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.

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.

Study Overview

• Status: Completed
• Conditions: Cartilage Diseases
• Intervention / Treatment: Device: MAC with NOVOCART Basic

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.

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68165
      • Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• Switzerland
  • Cantone Of Basel-Landschaft
    • Muttenz, Cantone Of Basel-Landschaft, Switzerland, 4132
      • Praxisklinik Rennbahn AG
  • Cantone Of Bern
    • Bern, Cantone Of Bern, Switzerland, 3012
      • Cartilage Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tetec AG
• Collaborators: Winicker Norimed GmbH; Aesculap AG
• Investigators: Principal Investigator: Bernhard Waibl, MD, Cartilage Care

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): July 24, 2019
• Study Completion (Actual): July 24, 2019

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: knee; cartilage defect; MAC (Matrix associated chondrogenesis)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: AAG-O-H-1712

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No