Dislocation, HipNCT04685239
Dual Mobility Cup Versus Unipolar Cup
A study testing dual mobility cup and unipolar cup in people with Dislocation, Hip, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
The general purpose of this study is to examine whether the dual mobility cup (Novae® Serf) reduces the number of hip dislocations after total hip replacement, both early dislocation (≤1 year) and late dislocation (>1 year) after primary THR compared with a conventional cup design (Trabecular MetalTM Modular… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dislocation, Hip
- What is being tested?
- dual mobility cup and unipolar cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2023to Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with hip arthritis who are amenable to surgery with THR and age ≥ 65 years referred to the Department of Orthopedic Surgery at either Section Farsø, Frederikshavn Hospital or Aalborg University Hospital. Patients who are willing to participate in the trial and who give their written, informed consent after receiving oral and written information.
Who cannot join
- Patients who do not wish to participate.
- Sequelae of Calvé-Legg-Perthes' disease, caput necrosis, epiphysiolysis.
- Proximal femoral or acetabular fracture.
- Hip dysplasia with subluxation Crowe types III and IV.
- Earlier hip bone surgery (excluding arthroscopic surgery).
- Elective bilateral surgery.
- If the patient's bone morphology is unsuitable for a cemented Exeter® femoral stem.
- Patients with no e-mail.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Jakobsen, MD, PhD contact
Denmark1 site
Aalborg University Hospital
Aalborg, Northen Denmark, 9000
Anders Diernæs, MD, +4597662503, anders.diernaes@rn.dk
Thomas Jakobsen, MD, PhD, thomas.jakobsen@rn.dk
About this study
Official title: Risk of Dislocation After Total Hip Replacement: Dual Mobility Cup vs. Unipolar Cup. A Randomized Controlled Trial With Patients ≥65 Years Operated for Hip Osteoarthritis With Primary Total Hip Replacement (THR).
The general purpose of this study is to examine whether the dual mobility cup (Novae® Serf) reduces the number of hip dislocations after total hip replacement, both early dislocation (≤1 year) and late dislocation (>1 year) after primary THR compared with a conventional cup design (Trabecular MetalTM Modular Acetabular System).
Read the detailed description
Surgery with THR for arthritis and other hip disorders has long been one of the most successful orthopedic surgical treatments. The majority of the patients gain pain relief and experience improved hip function. In 2017, a total of 10,691 THRs were implanted in Denmark (annual report 2018).
Hip dislocation is a known complication after THR. It is a painful condition which may have far-reaching consequences for the patient, who may experience both physical and mental discomfort. Ultimately, multiple hip dislocations may result in reoperation.
In the literature, the incidence of hip dislocation is reported at 2-6 %, and a more recent review reports a risk of 0.5-10 %.
In Denmark, recurrent hip dislocation is the cause of 21 % of the reoperations per year according to The Danish Hip Arthroplasty Register. According to the British National Joint Registry (NJR) and the Australian register (AOANJRR), hip dislocation is the cause of 15.5 % and 21 %, respectively, of the reoperations.
The best method to avoid reoperation due to instability is to choose the correct implant for the individual patient and thereby spare the patient of having to endure a painful complication and yet another procedure. There are multiple risk factors for instability after THR, and increased use of dual mobility cups (DMC) is already documented.
- Conditions
- Dislocation, Hip
- Being tested
- dual mobility cup, unipolar cup
- Keywords
- dislocation, hip, thr, dual mobility cup
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual mobility cupDevice
The use of a Sunfit dual mobility cup
unipolar cupDevice
The use of a TMT cup
| Study group | Role | What they receive |
|---|---|---|
| Unipolar cup | Active comparator | Patients randomized to receive a conventional unipolar acetabular cup Receives: Device: unipolar cup |
| dual mobility cup | Active comparator | Patients randomized to receive a double mobility acetabular cup Receives: Device: dual mobility cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early dislocation, Difference in dislocation within 1 year.
The primary outcome is the difference in cumulative incidence proportion of dislocation between the 2 randomized groups within the first year after total hip replacement. The information will be collected from both the patient through questionnaires and from the Danish Hip Arthroplasty Register and the Danish National Patient Register.
Measured: 1 year after surgery
Secondary outcomes (6)
Difference in dislocation within 5 years
The difference in cumulative incidence proportion of dislocation between the 2 randomized groups within 5 years after total hip replacement. The information will be collected from both the patient through questionnaires and from the Danish Hip Arthroplasty Register and the Danish National Patient Register.
Measured: 5 years after surgery
Dislocation 10 year
The difference in cumulative incidence proportion of dislocation between the 2 randomized groups within 10 years after total hip replacement. The information will be collected from both the patient through questionnaires and from the Danish Hip Arthroplasty Register and the Danish National Patient Register.
Measured: 10 years after surgery
Prosthesis survival.
Evaluated by the cumulative incidence of THR's reoperated within 1, 5 and 10 years after total hip replacement. The information will be collected from both the patient through questionnaires and from the Danish Hip Arthroplasty Register and the Danish National Patient Register.
Measured: 1, 5 and 10 year
Patient reported outcome measure: European quality of life 5 dimensions (EQ-5D 5L)
Patients will be scored with EQ-5D 5L preoperatively and at 1,5 and 10 years. It consists of 5 dimensions ranging from 1-5, with 1 being the best in each dimension. It also consist of a visual analog scale ranging from 0-100, 100 being the best imaginable health, The EQ VAS describes the respondents current overall health. Data will be showed as changes in health over time showing responses at baseline and at follow up or as frequencies and proportions reported by dimension and level.
Measured: 1, 5 and 10 years
Patient reported outcome measure: Oxford Hip Score (OHS)
Patients will be scored with OHS at baseline and at 1, 5 and 10 years. OHS is a patient-recorded outcome measure designed to assess the outcome of hip replacements. Its a score between 0-48 with 48 being the best.
Measured: 1, 5 and 10 years
Patient reported outcome measures: The Copenhagen Hip and Groin Outcome Score (HAGOS)
HAGOS pain subscale will be used to report pain pre and postoperatively. The score in the pain subscale ranges from 0 (extreme hip/groin problems) -100 (no hip/groin problems).
Measured: 1, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Apr 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dislocation, HipStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- controlled randomized trial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685239
- Sponsor's protocol ID
- N-20190040
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2020
- Last updated
- 27 Mar 2023
- 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Dislocation After Total Hip Replacement: Dual Mobility Cup vs. Unipolar Cup. A Randomized Controlled Trial With Patients ≥65 Years Operated for Hip Osteoarthritis With Primary Total Hip Replacement (THR).
- ClinicalTrials.gov ID
- NCT04685239
- Acronym / sponsor ID
- N-20190040
- Conditions
- Dislocation, Hip
- Keywords
- dislocation, hip, thr, dual mobility cup
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 28 Dec 2020 (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.
The general purpose of this study is to examine whether the dual mobility cup (Novae® Serf) reduces the number of hip dislocations after total hip replacement, both early dislocation (≤1 year) and late dislocation (>1 year) after primary THR compared with a conventional cup design (Trabecular MetalTM Modular Acetabular System).
Detailed description
Surgery with THR for arthritis and other hip disorders has long been one of the most successful orthopedic surgical treatments. The majority of the patients gain pain relief and experience improved hip function. In 2017, a total of 10,691 THRs were implanted in Denmark (annual report 2018).
Hip dislocation is a known complication after THR. It is a painful condition which may have far-reaching consequences for the patient, who may experience both physical and mental discomfort. Ultimately, multiple hip dislocations may result in reoperation.
In the literature, the incidence of hip dislocation is reported at 2-6 %, and a more recent review reports a risk of 0.5-10 %.
In Denmark, recurrent hip dislocation is the cause of 21 % of the reoperations per year according to The Danish Hip Arthroplasty Register. According to the British National Joint Registry (NJR) and the Australian register (AOANJRR), hip dislocation is the cause of 15.5 % and 21 %, respectively, of the reoperations.
The best method to avoid reoperation due to instability is to choose the correct implant for the individual patient and thereby spare the patient of having to endure a painful complication and yet another procedure. There are multiple risk factors for instability after THR, and increased use of dual mobility cups (DMC) is already documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Unipolar cup | Active comparator | Device: unipolar cupPatients randomized to receive a conventional unipolar acetabular cup |
| dual mobility cup | Active comparator | Device: dual mobility cupPatients randomized to receive a double mobility acetabular cup |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients with hip arthritis who are amenable to surgery with THR and age ≥ 65 years referred to the Department of Orthopedic Surgery at either Section Farsø, Frederikshavn Hospital or Aalborg University Hospital. Patients who are willing to participate in the trial and who give their written, informed consent after receiving oral and written information.
Key exclusion criteria (8 listed)
- Patients who do not wish to participate.
- Sequelae of Calvé-Legg-Perthes' disease, caput necrosis, epiphysiolysis.
- Proximal femoral or acetabular fracture.
- Hip dysplasia with subluxation Crowe types III and IV.
- Earlier hip bone surgery (excluding arthroscopic surgery).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual mobility cupThe use of a Sunfit dual mobility cup | Device | dual mobility cup |
| unipolar cupThe use of a TMT cup | Device | Unipolar cup |
Primary outcome
Early dislocation, Difference in dislocation within 1 year.
Time frame: 1 year after surgery
The primary outcome is the difference in cumulative incidence proportion of dislocation between the 2 randomized groups within the first year after total hip replacement. The information will be collected from both the patient through questionnaires and from the Danish Hip Arthroplasty Register and the Danish National Patient Register.
6 secondary outcomes
Difference in dislocation within 5 years
Time frame: 5 years after surgery
Dislocation 10 year
Time frame: 10 years after surgery
Prosthesis survival.
Time frame: 1, 5 and 10 year
Patient reported outcome measure: European quality of life 5 dimensions (EQ-5D 5L)
Time frame: 1, 5 and 10 years
Patient reported outcome measure: Oxford Hip Score (OHS)
Time frame: 1, 5 and 10 years
Patient reported outcome measures: The Copenhagen Hip and Groin Outcome Score (HAGOS)
Time frame: 1, 5 and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Thomas Jakobsen, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual mobility cup and unipolar cup in people with Dislocation, Hip, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders Diernæs, MD (+4597662503, anders.diernaes@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early dislocation, Difference in dislocation within 1 year. (time frame: 1 year after surgery). 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 27 Mar 2023.