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Total Hip Arthroplasty (THA)NCT06583382

Cementation of Cup and the Risk of Second Revision

An observational study of Total Hip Arthroplasty (THA) and Revision Hip Arthroplasty, run by Bispebjerg Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
60,000 participants
Where
No sites listed yet
Study dates
1 Oct 2024to 1 Oct 2026
How long will I take part?
15 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Saber M. Aljuboori, MD contact

004521299265

ssab0009@regionh.dk

About this study

Official title: Risk for Second Revision in Patients With Cemented Versus Non-cemented Acetabular Component at Primary THA. A National Cohort Study From DHR

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.

Read more

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.

Read the detailed description

Background Total hip arthroplasty (THA) is considered to be one of the most successful operations performed in orthopedic surgery and the treatment of choice for end-stage osteoarthritis of the hip. The frequency of revision surgery for total hip joint arthroplasty continues to increase worldwide. Generally, the longevity of revision THA is less than that of primary THA. Although the optimal component fixation method in primary THA is still debated, several studies have shown increased use of the cementless technique in most parts of the world. The use of cementless technology in THA initially gained popularity as complications such as aseptic loosening and "cement disease" began to surface with the use of first-generation cement techniques. Cementless acetabular components have achieved widespread acceptance in THA as a result of their improved and reliable long-term results. Primary stability is achieved through press-fit fixation that requires 1-3 mm under-reaming of the acetabular cavity and forceful impaction. Studies have shown slightly higher risk of revision in uncemented acetabular components compared to those cemented. We believe that the differences in the fixation method during the primary operation significantly affects the surgical techniques implemented in the first revision of each group and by that influencing the risk of second revision. This was shown before in cemented vs. uncemented stem, but no study has to our knowledge reported the same concerning acetabular components. In previous studies comparing the risk of revision in patients undergoing THA with cemented and hybrid fixation techniques (where the cup component is non-cemented), the hybrid technique was associated with a higher risk of revision for any reason compared to the cemented technique, regardless of the patient's sex and age. The justification for this difference in revision rates can be the use of cement in cup fixation. This suggests that the use of cement in cup fixation may provide certain advantages, such as increased stability or longevity, which could potentially lead to a lower risk of revision compared to non-cemented cup fixation. Therefore, further research and clinical considerations are necessary to fully understand the implications of cup fixation techniques in risk of THA revision. We expect that the result from this study would help in the choice of fixation technique by shedding light on an under investigated outcome concerning the complications associated with fixation technique.

Objective 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 Study design The current study is a nationwide register-based cohort study that utilizes prospectively collected data from the Danish Hip Arthroplasty Register (DHR) and the Danish National Patient Registry (DNPR). The study will follow the reporting of studies Conducted using Observational Routinely collected health Data (RECORD) guidelines. 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.

Data sources and linkage We will use data from the DHR and the DNPR. The DHR was founded in 1995 prospectively collects data on all THAs in public and private hospitals and their subsequent revisions in Denmark. Reporting from both public and private hospitals is mandatory. As of 2021, the DHR has a reporting rate of 97% for primary THAs and 95% for revisions. The DNPR is a national administrative database that registers all hospital contacts, including discharge diagnoses. All Danish residents have a unique 10-digit Civil Personal Register (CPR) number in the Danish Civil Registration System (DCRS) and this number enables to cross-link inhabitants in Denmark across different databases and to be traced until death or emigration.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06583382
Study groupRoleWhat they receive
Cemented CupPatients who received a cemented acetabular component in their primary THA and underwent a revision surgery of the component
Uncemented CupPatients who received an uncemented acetabular component in their primary THA and underwent a revision surgery of the component

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: minimum of 1 year and a maximum of 15 years

Secondary outcomes (1)
  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

    Measured: minimum of 1 year and a maximum of 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
60,000 participants (estimated)
Target duration
15 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06583382
Sponsor's protocol ID
P-2022-717
Status last verified
Sep 2024
First submitted
2 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Total Hip Arthroplasty (THA) and Revision Hip Arthroplasty, run by Bispebjerg Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Saber M. Aljuboori, MD (004521299265, ssab0009@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The absolute risk of second revision of the cup (time frame: minimum of 1 year and a maximum of 15 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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