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Cementation of Cup and the Risk of Second Revision

StatusUnknown
PhaseNot specified
Started
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Record status
This record was last updated September 19, 2024 (before its estimated October 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 3 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06583382
Lead Sponsor Bispebjerg Hospital
Conditions
(from sponsor)		 Total Hip Arthroplasty (THA), Revision Hip Arthroplasty
Enrollment 60,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov