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

Tissue Engineering Technologies (TETEC)

Status: Completed

Conditions: Cartilage Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02941120

AAG-O-H-1521

Details and patient eligibility

About

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

Full 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).

Enrollment: 245 patients

Sex: All

Ages: 14 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

245 participants in 1 patient group

NOVOCART® Inject patients

Description:

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