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NCT06583382

Cementation of Cup and the Risk of Second Revision

Not yet recruiting Last updated 19 September 2024
What this trial tests

trial in Total Hip Arthroplasty (THA) in 60,000 participants. Not yet recruiting.

Timeline
1 October 2024
Primary endpoint
1 October 2025
1 October 2026

Quick facts

Lead sponsorBispebjerg Hospital
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment60,000
Start date1 October 2024
Primary completion1 October 2025
Estimated completion1 October 2026

Conditions studied

Sponsor

Bispebjerg Hospital

Who can join

18 and older, any sex, with Total Hip Arthroplasty (THA) or Revision Hip Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Total Hip Arthroplasty (THA)

Currently open trials in the same condition.

Other Bispebjerg Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06583382.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing