Incidence and risk of heart failure in patients following metal-on-metal (MoM) hip arthroplasty

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31754
• EU PAS number:
  EUPAS31333
• Study ID:
  31754
• Official title and acronym:
  Incidence and risk of heart failure in patients following metal-on-metal (MoM) hip arthroplasty
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Ongoing

Research institutions and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Planned: 11/07/2019

Actual: 11/07/2019

Study start date

Planned: 09/09/2019

Actual: 09/09/2019

Date of final study report

Planned: 31/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Johnson & Johnson

Study protocol

Initial protocol

RWE19_SAF_004 Protocol_Final

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable