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

Study Overview
=================
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).

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)

Conditions
-----------------
Cartilage Disease

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NOVOCART® Inject patients<br>Patients who where treated with NOVOCART® Inject autologous chondrocyte implantation in the knee joint. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of IKDC 2000 | Outcome of the IKDC 2000 as measurements of symptoms and function | Up to 24 months | 
| Outcome of KOOS | Outcome of KOOS as measurements of symptoms and function | Up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cartilage defect, Knee, ACT (Autologous chondrocyte implantation), NOVOCART® Inject