Study identification

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 institutions and networks

Institutions

Contact details

Jennifer Wood

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Johnson & Johnson
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable