Primary Total Hip ArthroplastyDUALSIM-THANCT07464665
Comparing Dual-mobility Cups Versus Unipolar Cups for Unselected Primary Total Hip Arthroplasty by Direct Anterior Approach
A study testing Primary total hip arthroplasty using dual-mobility cup and Primary total hip arthroplasty using unipolar cup in people with Primary Total Hip Arthroplasty and Primary Total Hip Replacement, run by Elsan at 1 site in France.
Trial summary
THA comprises the replacement of the damaged bone and cartilage with prosthetic components. The proximal end of the femur is replaced with a stem and ball/head, while the acetabulum is most commonly replaced with a unipolar cup (UP) that consists of a liner inside of a metal shell. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Total Hip Arthroplasty, Primary Total Hip Replacement
- What is being tested?
- Primary total hip arthroplasty using dual-mobility cup and Primary total hip arthroplasty using unipolar cup
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2026to 1 Jul 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women aged ≥18 years old
- set to undergo elective primary THA via direct anterior approach (DAA)
- affiliated with a social security scheme
- able to answer questionnaires and to communicate freely in French
- who have been informed and have provided free, informed, and written consent (no later than the day of inclusion and before any examination required by the study)
Who cannot join
- with prior ipsilateral hip surgery
- with prior contralateral hip surgery
- that require acetabular cup diameters ≤50mm (because DM cups are not available from the same manufacturer for diameters ≤50mm, and UP cups require head diameters of 36mm and thus minimum cup diameters of 52mm)
- undergoing emergency or trauma surgery (e.g. femoral neck fractures)
- with any concomitant disease or disorder which, in the opinion of the surgeon, may put the patient at risk, notably of hip instability or dislocation (hip dysplasia, neuromuscular deficit, fracture sequelae…) or may influence the result of the study
- that are pregnant or breastfeeding
- under legal protection (guardianship or curatorship or deprived of liberty).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Polyclinique Jean Villar
Bruges, 33520
Nicolas Verdier, +33(0)535549569, dr.nicolas.verdier@gmail.com
About this study
Official title: Monocentric Randomised Controlled Trial Comparing Dual-mobility Cups Versus Unipolar Cups for Unselected Primary Total Hip Arthroplasty by Direct Anterior Approach
THA comprises the replacement of the damaged bone and cartilage with prosthetic components. The proximal end of the femur is replaced with a stem and ball/head, while the acetabulum is most commonly replaced with a unipolar cup (UP) that consists of a liner inside of a metal shell. UP cups are associated with risks of dislocations, especially in elderly and female patients, as well as in patients with lumbar stiffness or operated for femoral neck fractures. In fact, one of the most common reasons for early revision of UP cups are dislocations.
Dual-mobility (DM) cups were introduced in the 1970s by the French surgeon Gilles Bousquet, as an alternative to UP cups. They are made up of two articulations, a femoral head moving inside a mobile polyethylene liner, which in turn moves inside a metal shell. This design allows for a greater jump distance and range of motion (ROM) compared to UP cups, thus resulting in reduced rates of dislocation.
Read more
A recent systematic review that evaluated 5 case-control studies (549 DM cups vs 649 UP cups) and 3 registry studies (5935 DM cups vs 217362 UP) found that in case-control studies, the dislocation rates were 0.2% for DM cups versus 7.1% for UP cups (p=0.009). Furthermore, in registry studies the revision rates due to dislocation were 0.2% for DM cups versus 0.5% for UP cups (p=0.050).
Nonetheless, there have been some concerns associated with the use of DM cups, including intra-prosthetic dislocations (IPD), polyethylene wear, and iliopsoas impingement. Since the early 2000s, new improvements in the design of DM cups have nearly eliminated the risk of IPD, and the use of ultra-high molecular weight polyethylene (UHMWPE) has greatly reduced wear rates, even in young and active patients. Lastly, although some studies have reported iliopsoas impingement with DM cups, the impingement is usually against the optional fixations, and not against the mobile polyethylene insert.
The hypothesis of the present interventional randomised controlled trial (RCT) is that THA using DM cups will not provide inferior outcomes compared to THA using UP cups, in terms of hip awareness measured using the forgotten joint score (FJS).
- Being tested
- Primary total hip arthroplasty using dual-mobility cup, Primary total hip arthroplasty using unipolar cup
- Keywords
- total hip arthroplasty, THA, total hip replacement, THR, randomised controlled trial, RCT, unipolar cup, dual-mobility cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary total hip arthroplasty using dual-mobility cupProcedure or surgery
Also called Primary total hip replacement, THA, THR
Replacement of hip articulating surface.
Primary total hip arthroplasty using unipolar cupProcedure or surgery
Also called Primary total hip replacement, THA, THR
Replacement of hip articulating surface.
| Study group | Role | What they receive |
|---|---|---|
| THA with dual-mobility cup | Active comparator | The THA will be performed via the DAA. The liner will be made of highly-crosslinked vitamin-E infused polyethylene. The femoral head will be made of either metal or ceramic. The dual-mobility cup will always be cementless, while the stem will be cemented in female patients aged ≥75 years, as well as in any patient diagnosed with osteoporosis. A blunt dissection will be carried out through the tensor fasciae latae muscle (TFLM), between the sartorius and rectus femoris muscles. A femoral neck osteotomy will then be performed using an oscillating saw, and the femoral head will be removed with a corkscrew. The acetabular components and the selected liner according to the randomisation, will then be implanted.The femoral head will then be impacted onto the femoral stem, and the prosthesis will be reduced. Closure of the surgical site will be performed in layers. Receives: Procedure: Primary total hip arthroplasty using dual-mobility cup |
| THA with unipolar cup | Active comparator | The THA will be performed via the DAA. The liner will be made of highly-crosslinked vitamin-E infused polyethylene. The femoral head will be made of either metal or ceramic. The unipolar cup will always be cementless, while the stem will be cemented in female patients aged ≥75 years, as well as in any patient diagnosed with osteoporosis. A blunt dissection will be carried out through the tensor fasciae latae muscle (TFLM), between the sartorius and rectus femoris muscles. A femoral neck osteotomy will then be performed using an oscillating saw, and the femoral head will be removed with a corkscrew. The acetabular components and the selected liner according to the randomisation, will then be implanted.The femoral head will then be impacted onto the femoral stem, and the prosthesis will be reduced. Closure of the surgical site will be performed in layers. Receives: Procedure: Primary total hip arthroplasty using unipolar cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forgotten Joint Score between DM cup group and UP cup group
The primary outcome is defined as patient-reported hip awareness at 2 years postoperatively, measured using the Forgotten Joint Score (FJS). The FJS is a validated self-administered questionnaire that measures the patients' ability to forget about a joint as a result of successful treatment. The questionnaire comprises 12 items. Each item is scored using a 5-point Likert scale, ranging from "never" (0 points) to "mostly" (4 points). The final FJS score is calculated as the addition of all items, divided by the number of items answered. The mean score is then multiplied by 25, and that value is subtracted from 100. The FJS ranges from 0 to 100, with 100 corresponding to the best score: the patient has forgotten about their joint.
Measured: 2 years
Secondary outcomes (9)
Forgotten Joint Score between DM cup group and UP cup group
Patient-reported hip awareness at 3 months and 1 year postoperatively, measured using the FJS. The FJS is a validated self-administered questionnaire that measures the patients' ability to forget about a joint as a result of successful treatment. The questionnaire comprises 12 items. Each item is scored using a 5-point Likert scale, ranging from "never" (0 points) to "mostly" (4 points). The final FJS score is calculated as the addition of all items, divided by the number of items answered. The mean score is then multiplied by 25, and that value is subtracted from 100. The FJS ranges from 0 to 100, with 100 corresponding to the best score: the patient has forgotten about their joint.
Measured: 3 months and 1 year
To compare the patient's hip/groin pain between DM cups versus UP cups, as well as to compare the net change from baseline
Patient-reported hip/groin pain preoperatively and at 3 months, 1 year and 2 years postoperatively, measured using a numeric rating scale (NRS). The net change will be calculated at 3 months, 1 year and 2 years taking the preoperative value as baseline. The NRS ranges from 0 to 10, with 0 representing no pain, and 10 representing the maximum pain imaginable.
Measured: preoperatively, at 3 months, 1 year and 2 years
To compare the patient's hip function between DM cups versus UP cups
Patient-reported hip function preoperatively and at 3 months, 1 year and 2 years postoperatively, measured using the Oxford hip score (OHS). The OHS is a validated self-administered questionnaire that assesses disability, in terms of function and pain, in patients undergoing THA. The questionnaire comprises 12 items. Each item is scored using a 5-point Likert scale, from 0 to 4 points, with 0 representing the worst outcome and 4 the best. The final OHS score is calculated as the addition of all items. The OHS ranges from 0 to 48, with 48 corresponding to the best score.
Clinician-reported hip ROM preoperatively and at 3 months and 1 year postoperatively. ROM will be measured in degrees, in flexion, extension, internal rotation, external rotation, abduction, adduction.
Measured: preoperatively, at 3 months, 1 year and 2 years
To compare the patient's sports activity between DM cups versus UP cups
Patient-reported return to sports (yes/no) and time to return to sports (months) will be assessed at 1 year postoperatively.
Measured: 1 year
To compare the patient's sports activity between DM cups versus UP cups
The University of California Los Angeles (UCLA) activity score will be evaluated preoperatively, at 1 year and 2 years postoperatively. The UCLA activity score assesses physical activity in patients undergoing hip surgery. The questionnaire is a single-item 10-level-scale, ranging from 1-10, with 10 representing a highly physically active patient, and 1 representing a patient who is dependent on others and unable to leave home.
Measured: preoperatively, at 1 year and 2 years
To compare the patient's sexual activity between DM cups versus UP cups
Patient-reported return to sexual activity (yes/no) and time to return to sexual activity (months) will be assessed at 1 year postoperatively.
Measured: 1 year
To compare the patient's sexual activity between DM cups versus UP cups
If the patient has returned to sexual activities, they will be asked to complete the questionnaire developed by Rougereau et al.. The questionnaire has 3 items, each of which is presented separately: (i) frequency of sexual intercourse after THA compared to before THA (unable to perform intercourse, unchanged, decreased, increased); (iia) difficulties with resuming sexual activity (yes, no), if yes, (iib) for what reason? (apprehension, pain, discomfort, decreased libido, other); and (iiia) change in sexual positions compared to before THA (unable to perform intercourse, temporary, definitive, none), if temporary, (iiib) for how long? (less than 3 weeks, more than 3 weeks).
Measured: 1 year
To compare the patient's satisfaction with surgery between DM cups versus UP cups
Patient-reported satisfaction with surgery at 1 year postoperatively, measured using a NRS. The NRS ranges from 0 to 10, with 0 representing extremely dissatisfied, and 10 representing extremely satisfied.
Measured: 1 year
To compare adverse events (that may impact the objectives of the study) between DM cups versus UP cups
Adverse events that may impact the objectives of the study, as well as complications (e.g. fracture, infection, hematoma, limb length discrepancy, aseptic loosening, articular noise), reoperations, and implant revisions, will be collected throughout the study period, specifying the incidence, severity, and relationship to the surgery performed. Adverse events of interest will be dislocations and iliopsoas impingement.
Measured: intraoperatively, at 3 months, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start7 Jul 2026 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary 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
- Model description
- This study is a patient-blinded prospective monocentric interventional comparative randomised trial in parallel groups, to evaluate the non-inferiority of DM cups compared to unipolar cups for THA.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464665
- Sponsor's protocol ID
- 2025-A01817-42
- Acronym
- DUALSIM-THA
- Status last verified
- Jul 2026
- First submitted
- 2 Mar 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones HB, Hinkle AJ, Liu Y, Sambandam SN. Multivariate Analysis of Risk Factors for In-Hospital Dislocation Following Primary Total Hip Arthroplasty. J Clin Med. 2024 Jun 13;13(12):3456. doi: 10.3390/jcm13123456.
PubMed 38929981Fessy MH, Viste A, Philippot R, Belzile EL. Recent progress in dual mobility total hip arthroplasty: an irresistible French icon. Orthop Traumatol Surg Res. 2024 Oct;110(6):103993. doi: 10.1016/j.otsr.2024.103993. Epub 2024 Sep 10. No abstract available.
PubMed 39265929Jonker RC, van Beers LWAH, van der Wal BCH, Vogely HC, Parratte S, Castelein RM, Poolman RW. Can dual mobility cups prevent dislocation without increasing revision rates in primary total hip arthroplasty? A systematic review. Orthop Traumatol Surg Res. 2020 May;106(3):509-517. doi: 10.1016/j.otsr.2019.12.019. Epub 2020 Apr 8.
PubMed 32278733Varacallo MA, Luo TD, Johanson NA. Total Hip Arthroplasty Techniques. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507864/
PubMed 29939641
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Randomised Controlled Trial Comparing Dual-mobility Cups Versus Unipolar Cups for Unselected Primary Total Hip Arthroplasty by Direct Anterior Approach
- ClinicalTrials.gov ID
- NCT07464665
- Acronym / sponsor ID
- DUALSIM-THA / 2025-A01817-42
- Keywords
- total hip arthroplasty, THA, total hip replacement, THR, randomised controlled trial, RCT, unipolar cup, dual-mobility cup
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 11 Mar 2026 (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.
THA comprises the replacement of the damaged bone and cartilage with prosthetic components. The proximal end of the femur is replaced with a stem and ball/head, while the acetabulum is most commonly replaced with a unipolar cup (UP) that consists of a liner inside of a metal shell. UP cups are associated with risks of dislocations, especially in elderly and female patients, as well as in patients with lumbar stiffness or operated for femoral neck fractures. In fact, one of the most common reasons for early revision of UP cups are dislocations.
Dual-mobility (DM) cups were introduced in the 1970s by the French surgeon Gilles Bousquet, as an alternative to UP cups. They are made up of two articulations, a femoral head moving inside a mobile polyethylene liner, which in turn moves inside a metal shell. This design allows for a greater jump distance and range of motion (ROM) compared to UP cups, thus resulting in reduced rates of dislocation.
A recent systematic review that evaluated 5 case-control studies (549 DM cups vs 649 UP cups) and 3 registry studies (5935 DM cups vs 217362 UP) found that in case-control studies, the dislocation rates were 0.2% for DM cups versus 7.1% for UP cups (p=0.009). Furthermore, in registry studies the revision rates due to dislocation were 0.2% for DM cups versus 0.5% for UP cups (p=0.050).
Nonetheless, there have been some concerns associated with the use of DM cups, including intra-prosthetic dislocations (IPD), polyethylene wear, and iliopsoas impingement. Since the early 2000s, new improvements in the design of DM cups have nearly eliminated the risk of IPD, and the use of ultra-high molecular weight polyethylene (UHMWPE) has greatly reduced wear rates, even in young and active patients. Lastly, although some studies have reported iliopsoas impingement with DM cups, the impingement is usually against the optional fixations, and not against the mobile polyethylene insert.
The hypothesis of the present interventional randomised controlled trial (RCT) is that THA using DM cups will not provide inferior outcomes compared to THA using UP cups, in terms of hip awareness measured using the forgotten joint score (FJS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a patient-blinded prospective monocentric interventional comparative randomised trial in parallel groups, to evaluate the non-inferiority of DM cups compared to unipolar cups for THA.
| Arm | Type | Receives |
|---|---|---|
| THA with dual-mobility cup | Active comparator | Procedure: Primary total hip arthroplasty using dual-mobility cupThe THA will be performed via the DAA. The liner will be made of highly-crosslinked vitamin-E infused polyethylene. The femoral head will be made of either metal or ceramic. The dual-mobility cup will always be cementless, while the stem will be cemented in female patients aged ≥75 years, as well as in any patient diagnosed with osteoporosis. A blunt dissection will be carried out through the tensor fasciae latae muscle (TFLM), between the sartorius and rectus femoris muscles. A femoral neck osteotomy will then be performed using an oscillating saw, and the femoral head will be removed with a corkscrew. The acetabular components and the selected liner according to the randomisation, will then be implanted.The femoral head will then be impacted onto the femoral stem, and the prosthesis will be reduced. Closure of the surgical site will be performed in layers. |
| THA with unipolar cup | Active comparator | Procedure: Primary total hip arthroplasty using unipolar cupThe THA will be performed via the DAA. The liner will be made of highly-crosslinked vitamin-E infused polyethylene. The femoral head will be made of either metal or ceramic. The unipolar cup will always be cementless, while the stem will be cemented in female patients aged ≥75 years, as well as in any patient diagnosed with osteoporosis. A blunt dissection will be carried out through the tensor fasciae latae muscle (TFLM), between the sartorius and rectus femoris muscles. A femoral neck osteotomy will then be performed using an oscillating saw, and the femoral head will be removed with a corkscrew. The acetabular components and the selected liner according to the randomisation, will then be implanted.The femoral head will then be impacted onto the femoral stem, and the prosthesis will be reduced. Closure of the surgical site will be performed in layers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- men and women aged ≥18 years old
- set to undergo elective primary THA via direct anterior approach (DAA)
- affiliated with a social security scheme
- able to answer questionnaires and to communicate freely in French
- who have been informed and have provided free, informed, and written consent (no later than the day of inclusion and before any examination required by the study)
Key exclusion criteria (7 listed)
- with prior ipsilateral hip surgery
- with prior contralateral hip surgery
- that require acetabular cup diameters ≤50mm (because DM cups are not available from the same manufacturer for diameters ≤50mm, and UP cups require head diameters of 36mm and thus minimum cup diameters of 52mm)
- undergoing emergency or trauma surgery (e.g. femoral neck fractures)
- with any concomitant disease or disorder which, in the opinion of the surgeon, may put the patient at risk, notably of hip instability or dislocation (hip dysplasia, neuromuscular deficit, fracture sequelae…) or may influence the result of the study
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 |
|---|---|---|
| Primary total hip arthroplasty using dual-mobility cupAlso: Primary total hip replacement, THA, THRReplacement of hip articulating surface. | Procedure or surgery | THA with dual-mobility cup |
| Primary total hip arthroplasty using unipolar cupAlso: Primary total hip replacement, THA, THRReplacement of hip articulating surface. | Procedure or surgery | THA with unipolar cup |
Primary outcome
Forgotten Joint Score between DM cup group and UP cup group
Time frame: 2 years
The primary outcome is defined as patient-reported hip awareness at 2 years postoperatively, measured using the Forgotten Joint Score (FJS). The FJS is a validated self-administered questionnaire that measures the patients' ability to forget about a joint as a result of successful treatment. The questionnaire comprises 12 items. Each item is scored using a 5-point Likert scale, ranging from "never" (0 points) to "mostly" (4 points). The final FJS score is calculated as the addition of all items, divided by the number of items answered. The mean score is then multiplied by 25, and that value is subtracted from 100. The FJS ranges from 0 to 100, with 100 corresponding to the best score: the patient has forgotten about their joint.
9 secondary outcomes
Forgotten Joint Score between DM cup group and UP cup group
Time frame: 3 months and 1 year
To compare the patient's hip/groin pain between DM cups versus UP cups, as well as to compare the net change from baseline
Time frame: preoperatively, at 3 months, 1 year and 2 years
To compare the patient's hip function between DM cups versus UP cups
Time frame: preoperatively, at 3 months, 1 year and 2 years
To compare the patient's sports activity between DM cups versus UP cups
Time frame: 1 year
To compare the patient's sports activity between DM cups versus UP cups
Time frame: preoperatively, at 1 year and 2 years
To compare the patient's sexual activity between DM cups versus UP cups
Time frame: 1 year
To compare the patient's sexual activity between DM cups versus UP cups
Time frame: 1 year
To compare the patient's satisfaction with surgery between DM cups versus UP cups
Time frame: 1 year
To compare adverse events (that may impact the objectives of the study) between DM cups versus UP cups
Time frame: intraoperatively, at 3 months, 1 year and 2 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 16 Jul 2026.
- Background: PubMed 38929981Jones HB, Hinkle AJ, Liu Y, Sambandam SN. Multivariate Analysis of Risk Factors for In-Hospital Dislocation Following Primary Total Hip Arthroplasty. J Clin Med. 2024 Jun 13;13(12):3456. doi: 10.3390/jcm13123456.
- Background: PubMed 39265929Fessy MH, Viste A, Philippot R, Belzile EL. Recent progress in dual mobility total hip arthroplasty: an irresistible French icon. Orthop Traumatol Surg Res. 2024 Oct;110(6):103993. doi: 10.1016/j.otsr.2024.103993. Epub 2024 Sep 10. No abstract available.
- Background: PubMed 32278733Jonker RC, van Beers LWAH, van der Wal BCH, Vogely HC, Parratte S, Castelein RM, Poolman RW. Can dual mobility cups prevent dislocation without increasing revision rates in primary total hip arthroplasty? A systematic review. Orthop Traumatol Surg Res. 2020 May;106(3):509-517. doi: 10.1016/j.otsr.2019.12.019. Epub 2020 Apr 8.
- Background: PubMed 29939641Varacallo MA, Luo TD, Johanson NA. Total Hip Arthroplasty Techniques. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507864/
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary total hip arthroplasty using dual-mobility cup and Primary total hip arthroplasty using unipolar cup in people with Primary Total Hip Arthroplasty and Primary Total Hip Replacement, run by Elsan at 1 site in France.
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 5 inclusion and 7 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 16 Jul 2026. 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 France. 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 Nicolas Verdier (+33(0)535549569, dr.nicolas.verdier@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forgotten Joint Score between DM cup group and UP cup group (time frame: 2 years). 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 NCT07464665, which also lists 4 linked publications.
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 16 Jul 2026.