Risk Factors for Aseptic Loosening after Primary Total Knee Arthroplasty with Cemented Knee Implants (Aseptic Loosening - Total Knee Arthroplasty)

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:
  Device loosening

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  Primary Objective: Evaluate the risk of: (1) Aseptic loosening and (2) revision due to aseptic loosening in patients following primary total knee arthroplasty with cemented implants.Secondary Objective: Evaluate patient, implant, procedure and provider related risk factors associated with aseptic loosening and revision due to aseptic loosening.
• Outcomes:
  Diagnosis of aseptic loosening.Revision with primary diagnosis of aseptic loosening.
• Data analysis plan:
  Frequencies, proportions, means and standard deviations (SD) will be calculated to describe each database study population, and separately for patients with and without aseptic loosening (AL) diagnosis and AL revision procedures. Risk of AL and AL revision will be estimated at the following post-operative time points: 6 months, 1 year, 1.5 years, and yearly from 2 years onwards. A Kaplan-Meier analysis will be performed to evaluate risk of AL and AL revision over time, for the entire patient cohort. Poisson regressions will be used to model the incidence rates of AL and AL revision. A weighted Cox Regression analysis will be performed. Pooled estimates from results from the multiple data sources will be calculated using fixed and random-effect models, using DerSimonian & Laird (D.-L.) and Hartung-Knapp-Sidik-Jonkman (HKSJ) methods.