Cartilage Disease
Conditions
Keywords
cartilage defect, knee, pediatric patients
Brief summary
Prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART 3D in the Treatment fo cartilage defects of the knee in pediatric patients wieh closed epiphyseal growth plates.
Detailed description
The present study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® 3D in the treatment of cartilage defects of the knee in pediatric patients with closed epiphyseal growth plates. In this non-interventional study NOVOCART® 3D, which is marketed in Germany under Paragraph 4b Medicinal Products Act, will be used in routine clinical practice according to the authorized Summary of Product Characteristics (SmPC). As stated in this SmPC, NOVOCART® 3D may only be used by physicians who are trained on the product. The treatment with NOVOCART® 3D requires two surgeries. During the first surgery cartilage biopsies will be harvested arthroscopically and sent to TETEC AG (Tissue Engineering Technologies AG) for NOVOCART® 3D manufacturing, then NOVOCART® 3D will be transplanted during a second surgery about 3 to 4 weeks later. All patients will be followed up for 5 years post NOVOCART® 3D transplantation and data will be collected at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined at the end of this synopsis. NOVOCART® 3D post treatment rehabilitation should follow the recommendations given in the SmPC and during product training. The primary and secondary variables (see below) will be assessed after a follow-up of 24 month post NOVOCART® 3D transplantation (primary analysis). Long-term data will be assessed after an additional 3 years follow-up (follow-up analysis). The collected data will be documented using dedicated case report forms (CRFs) which are created and printed by TETEC AG.
Interventions
DRUGNOVOCART 3D
Autologous Chondrocyte Implantation
Sponsors
Aesculap AG
Winicker Norimed GmbH
Tetec AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 13 - 17 years old * Medicinal indication for NOVOCART 3D treatment
Exclusion criteria
• none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score) | 24 months Follow Up (FU) | Change of KOOS defined as the average of the 5 subscale scores (range 0-100, higher values represent a better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IKDC subjective | 24 month FU | Change of IKDC (International Knee Documentation Committee) subjective (range 0-100, higher values represent a better outcome) |
| pain VAS | 24 month FU | Change in pain VAS (Visual Analogue Scale) (range 0-10, higher values represent a better outcome) |
| MOCART | 24 month FU | In vivo Performance via MRI (Magnetic Resonance Imaging), MOCART Score (Magnetic Resonance Observation of Cartilage Repair Tissue) (range 0-100, higher values represent a better outcome) |
| KOOS responder rate | 24 month FU | KOOS responder rate defined as Proportion of patients with \> 10 Points improvement in KOOS |
| Change of 5 subscores KOOS | 24 months FU | Change of the 5 subscores of KOOS (range 0-100, higher values represent a better outcome) |
| Proportion of patients with Treatment failures | 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months | Proportion of patients with Treatment failures |
| Health economics variable (Days of missing work/school ) to NOVOCART 3D treatment | 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months | Days of missing work/school due to knee pain/function issues in the target knee |
| Health economics variable (Days of hospitalization ) to NOVOCART 3D treatment | 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months | Days of hospitalization due to knee pain/function issues in the target knee |
| Health economics variable (Number of postoperative doctor visits) to NOVOCART 3D treatment | 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months | Number of postoperative doctor visits |
| IKDC subjective responder rate | 24 months FU | IKDC subjective responder rate defined as Proportion of patients with \>20.5 Points improvement in IKDC subjective |
Countries
Germany
Outcome results
None listed