Prospective, Non-interventional Study to Evaluate the Efficacy and Safety of NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients With Closed Epiphyses
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cartilage Disease
- Sponsor
- Tetec AG
- Enrollment
- 42
- Locations
- 6
- Primary Endpoint
- Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score)
- Status
- Active, Not Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •13 - 17 years old
- •Medicinal indication for NOVOCART 3D treatment
- •Exclusion criteria:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time Frame: 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 Outcomes
- 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)
- Change of 5 subscores KOOS(24 months FU)
- IKDC subjective(24 month FU)
- pain VAS(24 month FU)
- MOCART(24 month FU)
- KOOS responder rate(24 month FU)
- IKDC subjective responder rate(24 months FU)
- Proportion of patients with Treatment failures(3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months)
- 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)
- 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)