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

NCT03808623 | Completed

• 1 other identifier: AAG-O-H-1712
• Study Type: observational
• Target: 41
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cartilage Diseases

Keywords

cartilage defect; knee; MAC (Matrix associated chondrogenesis)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Rate of therapy change

  Up to 5 years

• Rate of adverse device effects

  Up to 5 years

• Rate of device deficiencies

  Up to 5 years

• Rate of adverse events related to the procedure involved

  Up to 5 years

• KOOS

  Up to 5 years

Interventions

MAC with NOVOCART Basic DEVICE

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.

Also known as: MAC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tetec AG: lead
• Aesculap AG: collaborator
• Winicker Norimed GmbH: collaborator

Study Sites (3)

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Mannheim, Baden-Wurttemberg, 68165, Germany

Location

Praxisklinik Rennbahn AG

Muttenz, Cantone of Basel-Landschaft, 4132, Switzerland

Location

Cartilage Care

Bern, Cantone of Bern, 3012, Switzerland

Location

MeSH Terms

Conditions

Cartilage Diseases; Mycobacterium avium-intracellulare Infection

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Bernhard Waibl, MD

  Cartilage Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 17, 2019
• Study Start: April 9, 2018
• Primary Completion: July 24, 2019
• Study Completion: July 24, 2019
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

CH (2); DE (1)