Total Hip ArthroplastyREDEPNCT04031820
Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.
A study testing Unipolar cup and Dual mobility cup in people with Total Hip Arthroplasty and Osteoarthritis, Hip, run by JointResearch at 1 site in Netherlands.
Trial summary
Objective: The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in elderly patients 1 year after surgery. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Total Hip Arthroplasty, Osteoarthritis, Hip
- What is being tested?
- Unipolar cup and Dual mobility cup
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2019to 1 May 2027
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who are eligible for elective primary THA with a cemented cup, with a 32mm or 36 mm liner, for any indication.
- THA using posterolateral surgical approach.
- Patients ≥ 70 years old
- Adequate comprehension of written and spoken Dutch
Who cannot join
- Patients unable to complete PROMs
- Patients with dementia, epilepsy*, spasticity*, mental retardation or alcoholism. (If dementia or mental retardation is not already mentioned in the medical chart, this can be determined by doctors opinion.)
- Patients not eligible for either a unipolar or a DM cup
- These patients will be asked to participate in the non-randomized dual mobility observational cohort.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
OLVG
Amsterdam, 1091 AC
Loes van Beers, MSc, 020-5993653, l.w.a.h.vanbeers@olvg.nl
Nienke Willigenburg, PhD, 020-5992415, n.w.willigenburg@olvg.nl
About this study
Official title: Effectiveness of Dual-mobility Cups for Preventing Dislocation After Primary Total Hip Arthroplasty by a Posterolateral Approach and Their Cost-effectiveness Compared to Unipolar Cups in Elderly Patients.
Objective: The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in elderly patients 1 year after surgery.
Study design: Prospective multi-center nation wide, single blinded RCT nested in the LROI.
Study population: Patients ≥ 70 years old, undergoing an elective primary cemented THA.
Read the detailed description
Rationale: Dislocation is the leading reason for early revision surgery. To address the problem of dislocation, the dual-mobility (DM) cup was developed in France in the 1970's. This cup should provide more stability and biomechanically reduce the risk of dislocation. In the Netherlands, most DM cups are placed in specific patients, e.g. with cognitive impairment and for revisions due to recurrent dislocations. Despite the increased and, in some countries, broad use of DM cups, high quality evidence of their (cost)effectiveness is lacking. This study aims to perform a trial to fill this gap in knowledge. Much of the information needed to judge the effectiveness of DM cups is already incorporated in the Dutch Arthroplasty Register (LROI). This register lends itself perfectly for a nested RCT towards this aim.
Objective: The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in elderly patients 1 year after surgery. The secondary objectives are: to investigate whether there is a difference in the number of revisions; to investigate what the cost-effectiveness and cost-utility is of a DM cup compared to a unipolar cup at 1 year follow-up; to investigate whether there is a difference in the number of hip dislocations and revisions between a DM cup and a unipolar cup 2 years after surgery; to investigate whether there is a difference in patient reported outcomes between a DM cup compared to a unipolar cup 1 and 2 years after surgery; to compare the number of hip dislocations, revisions and PROM data between patients in the randomized DM group and patients in an observational cohort DM group. Finally, long-term survival of DM and unipolar cups will be evaluated based on revision and mortality data registered in the LROI.
Study design: Prospective multi-center nation wide, single blinded RCT nested in the LROI.
Study population: Patients ≥ 70 years old, undergoing an elective primary cemented THA.
Intervention (if applicable): The intervention group receives a THA with a dual mobility cup, the control group receives a THA with a unipolar cup.
Main study parameters/endpoints: Primary: The number of dislocations. Secondary: costs, patient reported outcomes and implant survival.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In addition to the benefits from regular care, the primary hip arthroplasty procedure, patients might benefit from randomization to receiving a DM cup. DM cups are designed to reduce the risk of hip dislocation, compared to a unipolar cup. Patients may undergo more thorough follow-up than non-study patients and may benefit from this increased surveillance compared with regular care. The only burden associated with study participation is the time needed to complete the cost questionnaires (all other outcomes are part of standard care).
- Conditions
- Total Hip Arthroplasty, Osteoarthritis, Hip
- Being tested
- Unipolar cup, Dual mobility cup
- Keywords
- Primary total hip arthroplasty, Dual Mobility cup
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unipolar cupProcedure or surgery
Cemented unipolar acetabulum cup for primary THA
Dual mobility cupProcedure or surgery
Cemented dual mobility acetabulum cup for primary THA
| Study group | Role | What they receive |
|---|---|---|
| unipolar cup | Active comparator | 550 patients will receive a total hip arthroplasty with a unipolar cup. Receives: Procedure: Unipolar cup |
| Dual Mobility cup | Active comparator | 550 patients will receive a total hip arthroplasty with a dual mobility cup. Receives: Procedure: Dual mobility cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dislocations
The total number of dislocations, regardless of type of treatment (i.e. closed repositioning or revision).
Measured: 1 year postoperative
Secondary outcomes (7)
Number of revision surgeries
Revision surgery of any component for any reason
Measured: 1 year postoperative
cost-effectiveness questionnaire
An economic evaluation will be performed from the societal perspective, for dislocation and Quality Adjusted Life Years (QALYs). Prevailing guidelines of Zorginstituut Nederland will be observed. All costs and consequences relevant to THA, hip dislocation and hip revision will be taken into account. To compare costs between groups, confidence intervals around the mean differences in costs at one year after THA will estimated using the bias-corrected and accelerated bootstrap method.
Measured: 1 year postoperative
Number of dislocations
Total number of dislocations
Measured: 2 years postoperative
Patient Reported Outcomes on physical functioning
Difference in patient reported outcomes on physical functioning following primary THA with a DM cup compared to a unipolar cup, measured with the Hip disability and Osteoarthritis Outcome Score Physical Short form (HOOS-PS). Interval level scores from 0 (no difficulty) to 100 (extreme difficulty).
Measured: 1 and 2 years postoperative
Patient Reported Outcomes on pain
Difference in patient reported outcomes on pain, following primary THA with a DM cup compared to a unipolar cup, measured with the Numeric Ratin Scale (NRS) for pain in rest and during weight bearing. 0 means no pain, 10 means the most extreme pain.
Measured: 1 and 2 years postoperative
Patient Reported Outcomes on quality of life
Difference in patient reported outcomes quality of life, following primary THA with a DM cup compared to a unipolar cup, measured with the EuroQol 5 Dimensions (EQ-5D). A higher score means a worse quality of life, a lower score means a better quality of life. For the visual analogue scale (part of the EQ-5D), the lowest means the worst an the highest score means the best health score.
Measured: 1 and 2 years postoperative
Implant survival
Long-term implant survival based on LROI revision and mortality data.
Measured: 5 - 10 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Jan 2019
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JointResearch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudolf Poolman, MD, PhD, Principal investigator, OLVG, Amsterdam, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031820
- Sponsor's protocol ID
- NL64819.100.18
- Acronym
- REDEP
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Beers LWAH, Van Der Wal BCH, Van Loon TG, Moojen DJF, Van Wier MF, Klaassen AD, Willigenburg NW, Poolman RW; Collaborator group. Study protocol: Effectiveness of dual-mobility cups compared with uni-polar cups for preventing dislocation after primary total hip arthroplasty in elderly patients - design of a randomized controlled trial nested in the Dutch Arthroplasty Registry. Acta Orthop. 2020 Oct;91(5):514-519. doi: 10.1080/17453674.2020.1798658. Epub 2020 Aug 4.
PubMed 32746668
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dual-mobility Cups for Preventing Dislocation After Primary Total Hip Arthroplasty by a Posterolateral Approach and Their Cost-effectiveness Compared to Unipolar Cups in Elderly Patients.
- ClinicalTrials.gov ID
- NCT04031820
- Acronym / sponsor ID
- REDEP / NL64819.100.18
- Conditions
- Total Hip Arthroplasty, Osteoarthritis, Hip
- Keywords
- Primary total hip arthroplasty, Dual Mobility cup
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- JointResearchUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Jul 2019 (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.
Objective: The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in elderly patients 1 year after surgery.
Study design: Prospective multi-center nation wide, single blinded RCT nested in the LROI.
Study population: Patients ≥ 70 years old, undergoing an elective primary cemented THA.
Detailed description
Rationale: Dislocation is the leading reason for early revision surgery. To address the problem of dislocation, the dual-mobility (DM) cup was developed in France in the 1970's. This cup should provide more stability and biomechanically reduce the risk of dislocation. In the Netherlands, most DM cups are placed in specific patients, e.g. with cognitive impairment and for revisions due to recurrent dislocations. Despite the increased and, in some countries, broad use of DM cups, high quality evidence of their (cost)effectiveness is lacking. This study aims to perform a trial to fill this gap in knowledge. Much of the information needed to judge the effectiveness of DM cups is already incorporated in the Dutch Arthroplasty Register (LROI). This register lends itself perfectly for a nested RCT towards this aim.
Objective: The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in elderly patients 1 year after surgery. The secondary objectives are: to investigate whether there is a difference in the number of revisions; to investigate what the cost-effectiveness and cost-utility is of a DM cup compared to a unipolar cup at 1 year follow-up; to investigate whether there is a difference in the number of hip dislocations and revisions between a DM cup and a unipolar cup 2 years after surgery; to investigate whether there is a difference in patient reported outcomes between a DM cup compared to a unipolar cup 1 and 2 years after surgery; to compare the number of hip dislocations, revisions and PROM data between patients in the randomized DM group and patients in an observational cohort DM group. Finally, long-term survival of DM and unipolar cups will be evaluated based on revision and mortality data registered in the LROI.
Study design: Prospective multi-center nation wide, single blinded RCT nested in the LROI.
Study population: Patients ≥ 70 years old, undergoing an elective primary cemented THA.
Intervention (if applicable): The intervention group receives a THA with a dual mobility cup, the control group receives a THA with a unipolar cup.
Main study parameters/endpoints: Primary: The number of dislocations. Secondary: costs, patient reported outcomes and implant survival.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In addition to the benefits from regular care, the primary hip arthroplasty procedure, patients might benefit from randomization to receiving a DM cup. DM cups are designed to reduce the risk of hip dislocation, compared to a unipolar cup. Patients may undergo more thorough follow-up than non-study patients and may benefit from this increased surveillance compared with regular care. The only burden associated with study participation is the time needed to complete the cost questionnaires (all other outcomes are part of standard care).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unipolar cup | Active comparator | Procedure: Unipolar cup550 patients will receive a total hip arthroplasty with a unipolar cup. |
| Dual Mobility cup | Active comparator | Procedure: Dual mobility cup550 patients will receive a total hip arthroplasty with a dual mobility cup. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients who are eligible for elective primary THA with a cemented cup, with a 32mm or 36 mm liner, for any indication.
- THA using posterolateral surgical approach.
- Patients ≥ 70 years old
- Adequate comprehension of written and spoken Dutch
Key exclusion criteria (4 listed)
- Patients unable to complete PROMs
- Patients with dementia, epilepsy*, spasticity*, mental retardation or alcoholism. (If dementia or mental retardation is not already mentioned in the medical chart, this can be determined by doctors opinion.)
- Patients not eligible for either a unipolar or a DM cup
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 |
|---|---|---|
| Unipolar cupCemented unipolar acetabulum cup for primary THA | Procedure or surgery | unipolar cup |
| Dual mobility cupCemented dual mobility acetabulum cup for primary THA | Procedure or surgery | Dual Mobility cup |
Primary outcome
Number of dislocations
Time frame: 1 year postoperative
The total number of dislocations, regardless of type of treatment (i.e. closed repositioning or revision).
7 secondary outcomes
Number of revision surgeries
Time frame: 1 year postoperative
cost-effectiveness questionnaire
Time frame: 1 year postoperative
Number of dislocations
Time frame: 2 years postoperative
Patient Reported Outcomes on physical functioning
Time frame: 1 and 2 years postoperative
Patient Reported Outcomes on pain
Time frame: 1 and 2 years postoperative
Patient Reported Outcomes on quality of life
Time frame: 1 and 2 years postoperative
Implant survival
Time frame: 5 - 10 years postoperative
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 28 Feb 2025.
- Derived from this study: PubMed 32746668Van Beers LWAH, Van Der Wal BCH, Van Loon TG, Moojen DJF, Van Wier MF, Klaassen AD, Willigenburg NW, Poolman RW; Collaborator group. Study protocol: Effectiveness of dual-mobility cups compared with uni-polar cups for preventing dislocation after primary total hip arthroplasty in elderly patients - design of a randomized controlled trial nested in the Dutch Arthroplasty Registry. Acta Orthop. 2020 Oct;91(5):514-519. doi: 10.1080/17453674.2020.1798658. Epub 2020 Aug 4.
- 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.
Rudolf Poolman, MD, PhD principal investigator
OLVG, Amsterdam, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unipolar cup and Dual mobility cup in people with Total Hip Arthroplasty and Osteoarthritis, Hip, run by JointResearch at 1 site in Netherlands.
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 4 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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 Netherlands. 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 Loes van Beers, MSc (+31205993653, l.w.a.h.vanbeers@olvg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dislocations (time frame: 1 year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04031820, which also lists 1 linked publication.
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 28 Feb 2025.