A cross-sectional study to evaluate the effectiveness of additional Risk Minimisation Measures: A Survey among surgeons to assess their knowledge and understanding of selected risks of InductOs (dibotermin alfa/ACS) in Europe

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  INDUCTOS

Population studied

• Short description of the study population:
  Physicians from Germany, France, Ireland and the United Kingdom who have implanted InductOs in the last 2 years.; ; Inclusion criteria; Participants of this study must have met the following inclusion criteria to be eligible to participate in this study:; 1. Physicians that have implanted InductOs in a lumbar interbody spine fusion procedure at least once in the 24 months prior to taking this survey; ; Exclusion criteria; Participants meeting any of the following criteria were not be included in the study:; 1. Physicians that participated in the testing of this survey, if there are substantial changes made to the survey post-pilot i.e. changes which, in the view of the research team, make the participants contributions invalid or potentially compromising of the study objectives.; 2. Physicians that either themselves work for or have immediate family members who work for Medtronic, third parties involved in this study, or a regulatory agency (EMA, MHRA, HPRA, ANSM, BfARM).
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Estimated number of subjects:
  55

Study design details

• Main study objective:
  The goal of this study is to assess the awareness of InductOs-using spine surgeons concerning heterotopic ossification in relation to the InductOs Risk Management Plan.
• Data analysis plan:
  The study population will include all physicians who are screened, are eligible for this study, and completed the questionnaire. All statistical summaries in this study will be descriptive. Frequencies and percentages, with 95 % confidence intervals (CIs) where appropriate, will be presented. Country specific data will be presented. Additional exploratory analyses and sensitivity analyses may be conducted to identify difference between groups of responders.