Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Cardiac failure congestive
Population studied

Age groups

Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

18000
Study design details

Main study objective

To estimate the incidence and evaluate the risk of heart failure among patients undergoing MoM arthroplasties of the hip compared with those with alternative types of arthroplasties (non-MoM)To estimate the incidence and evaluate the risk of heart failure among patients undergoing MoM arthroplasties of the hip compared with an age and gender similar Osteoarthritis cohort without arthroplasty

Outcomes

Heart failure cases diagnosed in the first 30-days post implantation (index date) will be excluded to prevent including cases of iatrogenic fluid overload due to the surgical procedure>= 2 recorded acute heart failure-related diagnosis codes, Heart failure cases diagnosed in the first 30-days post implantation (index date) will be excluded to prevent including cases of iatrogenic fluid overload due to the surgical procedure>= 2 recorded acute or chronic heart failure-related diagnosis codes

Data analysis plan

The goals of these analyses are to: 1) determine the characteristics of patients implanted with MoM and non-MOM hip implants and OA patients with arthroplasty, and 2) evaluate the risk of heart failure among patients with MoM implants compared to non-MOM implants or OA without arthroplasty.