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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31757
• EU PAS number:
  EUPAS31269
• Study ID:
  31757
• Official title and acronym:
  Risk Factors for Aseptic Loosening after Primary Total Knee Arthroplasty with Cemented Knee Implants (Aseptic Loosening - Total Knee Arthroplasty)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Aseptic loosening (AL) is a major cause of failure of total knee arthroplasty (TKA), accounting for up to 31% of all failures. A systematic review conducted by Cherian et al evaluated risk factors for AL following both TKA and total hip arthroplasty (THA) procedures. Although there were conflicting results across studies, some investigations reported that patient-related factors such as smoking and BMI were associated with AL. This study was designed to evaluate risk of AL and revision due to AL in patients with cemented TKA. A retrospective longitudinal cohort study is described herein, using data from claims and electronic health records from the US.Analyses include: Crude and adjusted cumulative incidence of AL and revision due to AL per post-index year. Survival analyses (Kaplan-Meier and weighted Cox models). Poisson regressions.Random-effect and fixed-effect models for aggregation of data from multiple databases, using DerSimonian & Laird (D.-L.) and Hartung-Knapp-Sidik-Jonkman (HKSJ) method.
• Study status:
  Ongoing

Research institution and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Planned: 03/09/2019

Actual: 09/09/2019

Study start date

Planned: 03/09/2019

Actual: 09/09/2019

Data analysis start date

Planned: 21/09/2019

Actual: 21/09/2019

Date of interim report, if expected

Planned: 01/11/2019

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_DEP_015 - Aseptic Loosening

Regulatory

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