Cementation of Cup and the Risk of Second Revision

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBispebjerg Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Primary osteoarthritis as the indication for the primary THA.

Has experienced a first revision with exchange of the liner, femoral head and/or acetabular component either with or without exchange of the femoral component.

Femoral with a size of 28mm, 32mm or 36mm after the first revision

Surgery with the posterior approach.

Disqualifiers

Isolated revision of the femoral component.

Constrained liner.

Metal-on-metal implant.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

60,000 Participants
are grouped into 2 trial groups

Locations

This trial has no locations

Sponsors and collaborators