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Cementation of Cup and the Risk of Second Revision

NCT06583382 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60000

Last updated 2024-09-19

No results posted yet for this study

Summary

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.

Conditions

  • Total Hip Arthroplasty (THA)
  • Revision Hip Arthroplasty

Sponsors & Collaborators

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Søren Overgard, MD, PhD, DMSc · Department of Orthopedic surgery and traumatology, Hvidovre Hospital, Copenhagen, Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-10-01
Completion
2026-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06583382 on ClinicalTrials.gov