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

Launched by TETEC AG · Oct 19, 2016

Keywords

ClinConnect Summary

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).

Gender

ALL

Eligibility criteria

• 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