Cementation of Cup and the Risk of Second Revision

NCT06583382 | Not Yet Recruiting DMC

• 1 other identifier: P-2022-717
• Study Type: observational
• Target: 60,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cup cementation; total hip arthroplasty; THA; Revision; Second Revision; Re-revision; cement

Outcome Measures

Primary Outcomes (1)

• The absolute risk of second revision of the cup

  The absolute risk of undergoing a second revision of the acetabular component after having first revision with exchange of the acetabular component. Revision is defined as any surgical procedure that involves skin incision in the ipsilateral hip joint due to acetabular component failure as reported in the Danish hip register or having one of the following NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures codes in the DNPR: KNFC2, KNFC01, KNFC3, KNFC4, KNFC10, KNFC11,KNFC21, KNFC31, KNFC41, KNFC29, KNFC20, KNFC40, KNFC49

  minimum of 1 year and a maximum of 15 years

Secondary Outcomes (1)

• The absolute risk of second revision of any other component

  minimum of 1 year and a maximum of 15 years

Study Arms (2)

Cemented Cup

Patients who received a cemented acetabular component in their primary THA and underwent a revision surgery of the component

Uncemented Cup

Patients who received an uncemented acetabular component in their primary THA and underwent a revision surgery of the component

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will include patients who have undergone THA at both public and private hospitals from January, 1st ,1995, to December 31st, 2020, to ensure a minimum follow-up of 1 year. Patients will be followed from the date of the first revision and until the first of the following: Implant removal of the acetabular component, death, emigration, until the date where there is a minimum of 100 patients left in the risk set for each group, or until December 31st, 2021.

You may qualify if:

• 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.

You may not qualify if:

• Isolated revision of the femoral component.
• Constrained liner.
• Metal-on-metal implant.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Officials

• Søren Overgard, MD, PhD, DMSc

  Department of Orthopedic surgery and traumatology, Hvidovre Hospital, Copenhagen, Denmark

  STUDY DIRECTOR

Central Study Contacts

Saber M. Aljuboori, MD

CONTACT

004521299265; ssab0009@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invistigator

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share