Non-interventional Study With NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients
- Conditions
- Cartilage Disease
- Registration Number
- NCT04186208
- Lead Sponsor
- Tetec AG
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 13 - 17 years old
- Medicinal indication for NOVOCART 3D treatment
Exclusion criteria:
• none
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Change of 5 subscores KOOS 24 months FU Change of the 5 subscores of KOOS (range 0-100, higher values represent a better outcome)
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
IKDC subjective responder rate 24 months FU IKDC subjective responder rate defined as Proportion of patients with \>20.5 Points improvement in IKDC subjective
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 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
Trial Locations
- Locations (6)
Sportklinik Stuttgart
🇩🇪Stuttgart, Baden Württemberg, Germany
Klinikum rechts der Isar der technischen Universität München
🇩🇪München, Bayern, Germany
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
🇩🇪Mannheim, Baden-Württemberg, Germany
Klinik und Poliklinik für Orthophädie, Physikalische Medizin und Rehabilitation Knie- und Schulterorthopädie
🇩🇪München, Bayern, Germany
Univerisätsklinikum Regensburg
🇩🇪Regensburg, Bayern, Germany
Lubinus Clinicum Kiel
🇩🇪Kiel, Schleswig-Holstein, Germany