Non-interventional Study in Pediatric Patients Treated With NOVOCART Inject in the Knee
- Conditions
- Cartilage Disease
- Registration Number
- NCT05391841
- Lead Sponsor
- Tetec AG
- Brief Summary
The study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® Inject in the treatment of cartilage defects of the knee in pediatric patients with radiologically proven closed epiphyseal growth plates.
- Detailed Description
In this non-interventional study NOVOCART® Inject, which is marketed in Germany under a license according to Section 4b of the AMG, will be used in routine clinical practice according to the current authorized Summary of Product Characteristics (SmPC). As stated in this SmPC, NOVOCART® Inject may only be used by physicians who are trained on the product. The treatment with NOVOCART® Inject requires two surgeries. During the first surgery cartilage tissue will be harvested arthroscopically and sent to TETEC AG for NOVOCART® Inject manufacturing, then NOVOCART® Inject will be transplanted during a second surgery about 3 to 4 weeks later.
All patients will be followed up for 5 years post NOVOCART® Inject implantation and data will be collected preoperatively and at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined at the end of this synopsis.
NOVOCART® Inject 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® Inject implantation (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 by TETEC AG.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 30
- Pediatric patients (< 18 years of age at implantation)
- Closure of the epiphysis adjacent to the biopsy harvest site or the defect to be treated confirmed by an adequate imaging modality
- Localized full-thickness cartilage defect (ICRS grade III or IV) of the knee
- Medicinal indication for NOVOCART® Inject treatment
see NOVOCART Inject SmPC
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Responder rate of overall KOOS 24-months Follow-up The overall Knee injury and Osteoarthritis Outcome Score (KOOS5) responder rate defined as the proportion of patients with ≥ 10 points improvement in the KOOS5 from baseline.
- Secondary Outcome Measures
Name Time Method Change of overall KOOS from baseline 24-months Follow-up Change of overall KOOS from baseline to the 24-month assessment, Knee Injury and Osteoarthritis Outcome Score, score 0-100, higher score shows better outcome
Change of the 5 sub-scores of the KOOS from baseline 24-months Follow-up Change of the 5 sub-scores of the KOOS from baseline to the 24-month assessment, Knee Injury and Osteoarthritis Outcome Score, score 0-100, higher score shows better outcome
Change of the IKDC subjective score from baseline 24-months Follow-up Change from baseline to the 24-month visit in the IKDC subjective score, international knee documentation committee, score 0-100, higher score shows better outcome
Number of postop physical therapy 24-months Follow up, 60-months Follow-up Number of postop physical therapy
Change in the IKDC surgeon's part from baseline 24-months Follow-up Change from baseline to the 24-month visit in the IKDC surgeon's part. international knee documentation committee, score 0-100, higher score shows better outcome
MOCART (MRI imaging) 24-months Follow-up In vivo performance measured by the assessment of the Magnetic Resonance, Observation of Cartilage Repair Tissue (MOCART) score, Magnetic Resonance Observation of Cartilage Repair Tissue, score 0-100, higher score shows better outcome
IKDC subjective score responder rate 24-months Follow-up IKDC subjective score responder rate, defined as the proportion of patients with \> 20.5 points improvement in the IKDC subjective score from baseline to the 24-month visit
Work/school status checklist 24-months Follow up, 60-months Follow-up Work/school status, changes due to injury in work or school status (pupil, worker full or part time, not working, job seeking)
Proportion of patients with treatment failure 24-months Follow up, 60-months Follow-up Proportion of patients with treatment failure
Days of work/school missed 24-months Follow up, 60-months Follow-up Days of work/school missed
Rate of unplanned re-operations 24-months Follow up, 60-months Follow-up Rate of unplanned re-operations: all unplanned reoperations and those related to NOVOCART® Inject treatment
Surgical time 24-months Follow up, 60-months Follow-up cut-to-suture time
Number of postop doctor visits 24-months Follow up, 60-months Follow-up Number of postop doctor visits
Days of hospitalisation 24-months Follow up, 60-months Follow-up Days of hospitalisation
Treatment-related adverse reactions (ARs) 24-months Follow up, 60-months Follow-up Treatment-related adverse reactions (ARs)
Patient satisfaction 24-months Follow up, 60-months Follow-up Patient questionnaire, 4 questions with 3 answer choices better, same, worse
Length of incision 24-months Follow up, 60-months Follow-up Length of incision
Trial Locations
- Locations (6)
St. Josefs-Hospital Cloppenburg gemeinnützige GmbH
🇩🇪Cloppenburg, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
OCM Klinik GmbH München
🇩🇪München, Germany
Klinikum rechts der Isar, Technische Universität München
🇩🇪München, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany