Cartilage Disease
Conditions
Keywords
NOVOCART Inject, Cartilage Defect, Pediatric Patients, Knee, Cartilage Injury
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.
Interventions
DRUGNOVOCART Inject
Autologous Chondrocyte Implantation
Sponsors
Winicker Norimed GmbH
Tetec AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
see NOVOCART Inject SmPC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of postop physical therapy | 24-months Follow up, 60-months Follow-up | Number of postop physical therapy |
| Treatment-related adverse reactions (ARs) | 24-months Follow up, 60-months Follow-up | Treatment-related adverse reactions (ARs) |
| 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 |
| Length of incision | 24-months Follow up, 60-months Follow-up | Length of incision |
| 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 |
| 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 |
| Proportion of patients with treatment failure | 24-months Follow up, 60-months Follow-up | Proportion of patients with treatment failure |
| 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 |
| 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) |
| Days of work/school missed | 24-months Follow up, 60-months Follow-up | Days of work/school missed |
| Patient satisfaction | 24-months Follow up, 60-months Follow-up | Patient questionnaire, 4 questions with 3 answer choices better, same, worse |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of device deficiencies - Application System | 24-months Follow up, 60-months Follow-up | Number of device deficiencies - Application System |
| Number of device deficiencies - number of product related issues | 24-months Follow up, 60-months Follow-up | Number of device deficiencies - number of product related issues |
| Adverse reactions | 24-months Follow up, 60-months Follow-up | Continuous assessment of adverse reactions (ARs) |
| Number of device deficiencies - trephine | 24-months Follow up, 60-months Follow-up | Number of device deficiencies - trephine |
Countries
Germany
Outcome results
None listed