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

NCT02941120 | Completed

• 1 other identifier: AAG-O-H-1521
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 7

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.

Conditions

Cartilage Disease

Keywords

Cartilage defect; Knee; ACT (Autologous chondrocyte implantation); NOVOCART® Inject

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Outcome of IKDC 2000

  Up to 24 months

• Outcome of KOOS

  Up to 24 months

Study Arms (1)

NOVOCART® Inject patients

Patients who where treated with NOVOCART® Inject autologous chondrocyte implantation in the knee joint.

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Orthopaedic clinics

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (7)

Hochtaunus-Kliniken gGmbH Krankenhaus Bad Homburg

Bad Homburg, 61348, Germany

Location

Gelenk-Klinik Gundelfingen

Gundelfingen, 79194, Germany

Location

Orthopädische Praxisklinik im Zentrum

Kelkheim, 65779, Germany

Location

Orthopädische Klinik Markgröningen gGmbH

Markgröningen, 71706, Germany

Location

Dr. med. Michael Moraldo, Dr. med. Sebastian Lauber

Münster, 48165, Germany

Location

Nordwest-Krankenhaus Sanderbusch gGmbH

Sande, 26452, Germany

Location

Muldentalkliniken GmbH Krankenhaus Wurzen

Wurzen, 04808, Germany

Location

MeSH Terms

Conditions

Cartilage Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

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

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 21, 2016
• Study Start: December 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-01

Locations

DE (7)