Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects

Cartilage Disease Clinical Trial

— RENOVO  

Official title:

Retrospective Observational Study for Reconstruction of Localized, Full-thickness Cartilage Defects in the Knee Joint With In-situ Polymerizable and Chondrocyte Populated Biomaterial (NOVOCART® Inject)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941120
• Other study ID #: AAG-O-H-1521
• Status: Completed
• Start date: December 2015
• Est. completion date: May 2019

Study information

• Verified date: January 2019
• Source: Tetec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.

Description:

Retrospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with localized full-thickness cartilage defects in the knee joint.

Safety: Measuring the number of adverse drug reactions/serious adverse drug reactions since treatment and up to the present time.

Efficacy: Evaluate symptoms and functional status at the present time using IKDC 2000 (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome score).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

Inclusion Criteria:

• male and female patients

• juvenile patients with closed epiphysial plate

• insulated full-thickness cartilage damage of the knee Joint, ICRS (International Cartilage Repair Society) grade 3-4

• defect size = 2.5 and = 10 cm2

• intact or reconstructed bony subchondral plate

• in the case of deep bony substance defects, additional bony reconstruction is needed

Exclusion Criteria:

• radiographic signs of osteoarthritis of Kellgren and Lawrence > 2

• joint stiffness

• arthrofibrosis

• malalignment in the knee (valgus- or varus deformity) > 3° (correction contemporary to the ACT)

• insufficient reconstructed ligaments (correction contemporary to the ACT)

• defective position patella (correction contemporary to the ACT)

• sled prosthesis implants or carbon pin

• inflammatory joint diseases (f.e. rheumatoid arthritis)

• corresponding cartilage defects ("kissing lesions")

• more than two independent cartilage defects in one knee

• primary cartilage reconstructive treatment in children and juvenile with open epiphysial plate

• diffuse chondromalacia

• congenital or gained deformity of patella

Related Conditions & MeSH terms

• Cartilage Disease
• Cartilage Diseases

Locations

Country	Name	City	State
Germany	Hochtaunus-Kliniken gGmbH Krankenhaus Bad Homburg	Bad Homburg
Germany	Gelenk-Klinik Gundelfingen	Gundelfingen
Germany	Orthopädische Praxisklinik im Zentrum	Kelkheim
Germany	Orthopädische Klinik Markgröningen gGmbH	Markgröningen
Germany	Dr. med. Michael Moraldo, Dr. med. Sebastian Lauber	Münster
Germany	Nordwest-Krankenhaus Sanderbusch gGmbH	Sande
Germany	Muldentalkliniken GmbH Krankenhaus Wurzen	Wurzen

Sponsors (3)

Lead Sponsor	Collaborator
Tetec AG	Aesculap AG, Winicker Norimed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse drug reaction/serious adverse drug reaction	Number of adverse drug reaction/serious adverse drug reaction as a measurement of safety	Up to 24 months
Secondary	Outcome of IKDC 2000	Outcome of the IKDC 2000 as measurements of symptoms and function	Up to 24 months
Secondary	Outcome of KOOS	Outcome of KOOS as measurements of symptoms and function	Up to 24 months