Cementation of Cup and the Risk of Second Revision

Background: The fixation method of the acetabular component during the primary total hip arthroplasty (THA) affects the surgical techniques implemented in the revision surgery and may influence the risk of second revision. Objectives: The objectives of this study are to investigate the risk of second revision of the cup alone or any component after first cup revision following cemented or non-cemented cup in the primary THA. Methods/design: The study is a nationwide register-based cohort study and will follow the reporting of studies Conducted using Observational Routinely collected health Data (RECORD) guidelines. We will compare the risk of undergoing a second revision between cemented and uncemented revised acetabular component by reporting the absolute risk of second revision of 1) the acetabular component and 2) any other component. The cumulative incidence of revision will be estimated using Fine-Gray regression to model the cumulative incidence function, accounting for the competing risk of death. We will apply both a crude and a multivariable adjusted model adjusting for age, sex, Charlson Comorbidity Index (CCI) and the 5-year intervals during which the primary operation was performed.

NCT Number	NCT06583382
Lead Sponsor	Bispebjerg Hospital
Conditions	Total Hip Arthroplasty (THA), Revision Hip Arthroplasty
Enrollment	60,000 participants
Start Date	2024-10-01
Primary Completion	2025-10-01 (estimated)
Study Completion	2026-10-01 (estimated)
Updated on ClinicalTrials.gov	2024-09-19