Prospective non-interventional investigation to evaluate the long-term safety and linked efficacy of the three-dimensional autologous chondrocyte implantation product in paediatric patients from 15 to less than 18 years of age treated with the product (cod16 HS17 paed)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Open-label, multicentre surveillance study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (M09AX02) chondrocytes, autologous

  chondrocytes, autologous
• Medical condition to be studied:
  Cartilage injury

Population studied

• Short description of the study population:
  Male or female patients aged ≥15 years but <18 years at the time of implantation, who had undergone treatment with co.don chondrosphere®, with the treatment administered between 1 and 8 years before enrolment into the study.; Patients who meet the following criteria can be considered for inclusion into the investigation:; 1. Male or female patients being at least 15 but less than 18 years of age at the time of implantation; 2. Treatment with co.don chondrosphere® until December 2011; 3. Treatment is conducted max. 8 years before enrolment; 4. Written informed consent has been obtained.; Exclusion criteria; 1. There are no specific exclusion criteria in this non-interventional study.
• Age groups:
  • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  80

Study design details

• Main study objective:
  The overall research goal is to assess the long-term safety and linked efficacy of the three-dimensional autologous chondrocyte implantation product co.don chondrosphere® (ACI-M) in paediatric patients from 15 to less than 18 years of age at the time of implantation. Primary safety parameter is treatment failure rate.
• Outcomes:
  Treatment failure rate of autologous chondrocyte implantation product co.don chondrosphere®. For all patients (FAS):- Incidence of surgical treatments - Pain, knee function (measured by the KOOS)- QoL as measured by the KOOS and IKDC Subjective Knee Evaluation Form- Global patient assessment of treated knee measured by IKDC Subjective Knee Evaluation Form and modified Lysholm Knee ScoringFor patients that undergo physical examinations:- Average time to treatment failure
• Data analysis plan:
  All variables will be analysed in an exploratory manner with appropriate descriptive statistical methods: categorical variables by frequency tables (absolute and relative frequencies) and continuous variables by sample statistics (i.e. mean, standard deviation, minimum, median, quartiles and maximum).An additional subgroup analysis for patients with closed epiphyseal growth plate, patients with open epiphyseal growth plate, and patients with this information being missing, respectively, is planned.Data will be compared to the results for adult data of patients from 18 to less than 35 years of age.Statistical analyses will be performed using validated statistical software. (e.g. SAS, SAS Institute Inc.)All statistical details including calculated variables and proposed format and content of tables will be detailed in the statistical analysis plan (SAP).