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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
60,000 Participants
are grouped into 2 trial groupsGroup A: Cemented Cup
Group B: Uncemented Cup
Trial outcomes
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
Time frame
minimum of 1 year and a maximum of 15 yearsSecondary outcomes
1
The absolute risk of second revision of any other component
The absolute risk of undergoing a second revision of any other 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 Danish national patient register: KNFC02, KNFC20, KNFC22, KNFC23, KNFC32, KNFC33, NFC42, KNFC43, KNFC59, KNFC99, KNFA0, KNFA1, KNFA2, KNFG09, KNFS19, KNFS49, NFS99, KNFW49, KNFW69, KNFW89, KNFW99, KNFW59, KNFW79, NFU1Y, NFU89, NFU99, NFT99, NFP29
Time frame
minimum of 1 year and a maximum of 15 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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