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

Completed

• Conditions: Cartilage Disease

• Registration Number: NCT02941120
• Lead Sponsor: Tetec AG

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Status Verified: 2019-01
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of adverse drug reaction/serious adverse drug reaction	Up to 24 months	Number of adverse drug reaction/serious adverse drug reaction as a measurement of safety

Secondary Outcome Measures

Name	Time	Method
Outcome of IKDC 2000	Up to 24 months	Outcome of the IKDC 2000 as measurements of symptoms and function
Outcome of KOOS	Up to 24 months	Outcome of KOOS as measurements of symptoms and function

Trial Locations

Locations (7)

Orthopädische Praxisklinik im Zentrum; 🇩🇪 Kelkheim, Germany

Hochtaunus-Kliniken gGmbH Krankenhaus Bad Homburg; 🇩🇪 Bad Homburg, Germany

Gelenk-Klinik Gundelfingen; 🇩🇪 Gundelfingen, Germany

Orthopädische Klinik Markgröningen gGmbH; 🇩🇪 Markgröningen, Germany

Nordwest-Krankenhaus Sanderbusch gGmbH; 🇩🇪 Sande, Germany

Muldentalkliniken GmbH Krankenhaus Wurzen; 🇩🇪 Wurzen, Germany

Dr. med. Michael Moraldo, Dr. med. Sebastian Lauber; 🇩🇪 Münster, Germany