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.
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
- Conditions the study is for
- Total Hip Arthroplasty (THA), Revision Hip Arthroplasty
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted4 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saber Muthanna Saber, Bispebjerg Hospital
- Investigators
- Søren Overgard, MD, PhD, DMSc, Study director, Department of Orthopedic surgery and traumatology, Hvidovre Hospital, Copenhagen, Denmark
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk for Second Revision in Patients With Cemented Versus Non-cemented Acetabular Component at Primary THA. A National Cohort Study From DHR
- ClinicalTrials.gov ID
- NCT06583382
- Acronym / sponsor ID
- P-2022-717
- Keywords
- Cup cementation, total hip arthroplasty, THA, Revision, Second Revision, Re-revision, cement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 15 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Isolated revision of the femoral component.
- Constrained liner.
- Metal-on-metal implant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The absolute risk of second revision of the cup
Time frame: minimum of 1 year and a maximum of 15 years
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
1 secondary outcome
The absolute risk of second revision of any other component
Time frame: minimum of 1 year and a maximum of 15 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Total Hip Arthroplasty (THA)
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)
Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
Enrolling by invitationPhase 2
Efficacy of Intravenous Oxytocin to Speed Recovery After THA
Total Hip Arthroplasty
Enrolling by invitationPhase 3
A Clinical Trial Evaluating the Efficacy and Safety of Local Infiltration of RF16001 for Injection for Analgesia After Total Hip Arthroplasty in China
Pain After Abdominal Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Overgard, MD, PhD, DMSc study director
Department of Orthopedic surgery and traumatology, Hvidovre Hospital, Copenhagen, Denmark
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.