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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/42240
• EU PAS number:
  EUPAS32916
• Study ID:
  42240
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Ireland

  United Kingdom
• Study description:
  A cross-sectional study to evaluate the effectiveness of additional Risk Minimisation Measures for InductOs, more specifically of the educational materials that are distributed. This will be done through a survey among surgeons to assess their knowledge and understanding of the risk of occurrence of heterotopic ossification, and the related measures to minimize the occurrence of these risks.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 27/11/2019

Study start date

Planned: 21/09/2020

Actual: 01/10/2020

Date of final study report

Planned: 31/12/2020

Actual: 10/03/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Medtronic BioPharma B.V.

Study protocol

Initial protocol

Protocol_PASS_InductOs_ effectiveness aRMM

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)