Hip Arthroplasty ReplacementCUPUSURENCT07207005
Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip Arthroplasty
A study testing ECIMA CORIN and CORIN in people with Hip Arthroplasty Replacement, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
In 2022, data from the UK's National Joint Registry (NJR) and the American Joint Replacement Registry (AJRR) indicated that Total Hip Replacement (THR) is the most commonly performed orthopaedic joint surgery. The NJR has observed that between 10 and 20% of hip implants require revision within the first 10 years. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Hip Arthroplasty Replacement
- What is being tested?
- ECIMA CORIN and CORIN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2026to 31 Dec 2038
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, aged between 55 and 80.
- Patient with a life expectancy > 5 years at the time of inclusion.
- Patient scheduled to undergo primary total hip arthroplasty with a dual-mobility cup prosthesis.
- Patient affiliated with or beneficiary of a social security scheme.
- Patient who speaks French and has signed an informed consent form.
Who cannot join
- Patients with a contraindication mentioned in the instructions for use of the medical device under investigation
- Patients with an ASA score of 4
- Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision
- Patients participating in another clinical study whose objectives could interfere with this study
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
Hôpital Privé Jean Mermoz
Lyon, France, 69008
Jean LANGLOIS, MD, +33 6 03 29 45 33, jeangast@gmail.com
About this study
In 2022, data from the UK's National Joint Registry (NJR) and the American Joint Replacement Registry (AJRR) indicated that Total Hip Replacement (THR) is the most commonly performed orthopaedic joint surgery.
The NJR has observed that between 10 and 20% of hip implants require revision within the first 10 years. The main reasons for these revisions include implant fractures, joint incompatibility, aseptic loosening, dislocation and wear of the polyethylene (PE) insert.
Read more
To address this problem, highly cross-linked polyethylene (HXLPE) inserts have been developed. Cross-linking helps to limit wear on polyethylene prostheses in total hip arthroplasty. However, there are concerns about the loss of elasticity of HXLPE and oxidation after implantation.
A new generation of inserts based on highly cross-linked polyethylene (irradiation dose ≥100 Kgy), enriched with vitamin E, has been developed. This PE, called ECIMA, was developed to maintain mechanical properties, minimise PE wear and improve long-term oxidation resistance.
In the HAS evaluation report on highly cross-linked polyethylene inserts dated 24 January 2023, data from the literature show less wear of highly cross-linked polyethylene compared to conventional polyethylene.
Nevertheless, the use of highly cross-linked polyethylene is not yet the gold standard. Furthermore, the data in the literature mainly concern single-mobility cups but not double-mobility cups. Finally, new imaging protocols now make it possible to assess the wear of prosthesis materials more accurately.
In this context, it seems appropriate to conduct a French study comparing double-mobility cups containing highly cross-linked polyethylene or conventional polyethylene inserts.
Read the detailed description
In 2022, data from the UK's National Joint Registry (NJR) and the American Joint Replacement Registry (AJRR) indicated that total hip arthroplasty or Total Hip Replacement (THR) is the most commonly performed orthopaedic joint surgery.
THR involves replacing worn and damaged areas of cartilage in the hip with artificial parts of similar shape and size. A total hip replacement consists of two parts:
- A part designed to replace the head of the femur: a spherical prosthesis mounted on a stem that is inserted into the femur;
- A part designed to replace the acetabulum: the acetabular cup. There are single-mobility cups and double-mobility cups, where an insert is positioned on the metal head inside a single-mobility cup. Introduced in the 1960s by Sir John Charnley, UHMWPE (Ultra High Molecular Weight Polyethylene) remains the most widely used material for inserts in 2024.
The NJR has observed that between 10 and 20% of hip implants require revision within the first 10 years. The main reasons for these revisions include implant fractures, joint incompatibility, aseptic loosening, dislocation and wear of the polyethylene (PE) insert.
To address this problem, highly cross-linked polyethylene (HXLPE) inserts have been developed. Cross-linking helps to limit wear on polyethylene prostheses in total hip arthroplasty. However, there are concerns about the loss of elasticity of HXLPE and oxidation after implantation.
A new generation of inserts based on highly cross-linked polyethylene (irradiation dose ≥100 Kgy), enriched with vitamin E, has been developed. This PE, called ECIMA, was developed to maintain mechanical properties, minimise PE wear and improve long-term oxidation resistance.
In the HAS evaluation report on highly cross-linked polyethylene inserts dated 24 January 2023, data from the literature show less wear of highly cross-linked polyethylene compared to conventional polyethylene.
Nevertheless, the use of highly cross-linked polyethylene is not yet the gold standard. Furthermore, the data in the literature mainly concern single-mobility cups but not double-mobility cups. Finally, new imaging protocols now make it possible to assess the wear of prosthesis materials more accurately.
In this context, it seems appropriate to conduct a French study comparing double-mobility cups containing highly cross-linked polyethylene or conventional polyethylene inserts.
In the principal investigator's current practice, prostheses with conventional PE inserts are used for patients aged 70 or over, while prostheses with highly cross-linked PE inserts are used for patients under 70. However, this age-based choice is modulated favourably or unfavourably by two other parameters: the patient's medical history and general condition.
- Conditions
- Hip Arthroplasty Replacement
- Being tested
- ECIMA CORIN, CORIN
- Keywords
- Hip Arthroplasty Insert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECIMA CORINDevice
Mobile cup (Corin) made of highly cross-linked PE doped with vitamin E (ECIMA, Corin).
CORINDevice
Mobile cupule (Corin) is made of conventional PE
| Study group | Role | What they receive |
|---|---|---|
| Highly cross-linked PE | Experimental | The hip prosthesis will be a MOBILIT acetabular cup (Corin), MEIJE femoral stem (Corin), 28 mm diameter metal ball (Corin), and mobile cup (Corin) made of highly cross-linked PE doped with vitamin E (ECIMA, Corin). Receives: Device: ECIMA CORIN |
| Conventional PE | Active comparator | The hip prosthesis will be a MOBILIT (Corin) acetabular prosthesis, MEIJE (Corin) femoral stem, 28 mm diameter metal ball (Corin), and mobile cup (Corin) in conventional PE. Receives: Device: CORIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral head penetration into the acetabulum
Femoral head penetration into the acetabulum will be measured in mm/year, based on a hip X-ray and PolyWare® software, Rev 8, Draftware Inc, North Webster, IN, USA
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start30 Jul 2026
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Arthroplasty ReplacementStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207005
- Sponsor's protocol ID
- 2024-A02615-42
- Acronym
- CUPUSURE
- Status last verified
- Aug 2025
- First submitted
- 26 Sep 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07207005
- Acronym / sponsor ID
- CUPUSURE / 2024-A02615-42
- Conditions
- Hip Arthroplasty Replacement
- Keywords
- Hip Arthroplasty Insert
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 31 Dec 2038 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 3 Oct 2025 (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.
In 2022, data from the UK's National Joint Registry (NJR) and the American Joint Replacement Registry (AJRR) indicated that Total Hip Replacement (THR) is the most commonly performed orthopaedic joint surgery.
The NJR has observed that between 10 and 20% of hip implants require revision within the first 10 years. The main reasons for these revisions include implant fractures, joint incompatibility, aseptic loosening, dislocation and wear of the polyethylene (PE) insert.
To address this problem, highly cross-linked polyethylene (HXLPE) inserts have been developed. Cross-linking helps to limit wear on polyethylene prostheses in total hip arthroplasty. However, there are concerns about the loss of elasticity of HXLPE and oxidation after implantation.
A new generation of inserts based on highly cross-linked polyethylene (irradiation dose ≥100 Kgy), enriched with vitamin E, has been developed. This PE, called ECIMA, was developed to maintain mechanical properties, minimise PE wear and improve long-term oxidation resistance.
In the HAS evaluation report on highly cross-linked polyethylene inserts dated 24 January 2023, data from the literature show less wear of highly cross-linked polyethylene compared to conventional polyethylene.
Nevertheless, the use of highly cross-linked polyethylene is not yet the gold standard. Furthermore, the data in the literature mainly concern single-mobility cups but not double-mobility cups. Finally, new imaging protocols now make it possible to assess the wear of prosthesis materials more accurately.
In this context, it seems appropriate to conduct a French study comparing double-mobility cups containing highly cross-linked polyethylene or conventional polyethylene inserts.
Detailed description
In 2022, data from the UK's National Joint Registry (NJR) and the American Joint Replacement Registry (AJRR) indicated that total hip arthroplasty or Total Hip Replacement (THR) is the most commonly performed orthopaedic joint surgery.
THR involves replacing worn and damaged areas of cartilage in the hip with artificial parts of similar shape and size. A total hip replacement consists of two parts:
- A part designed to replace the head of the femur: a spherical prosthesis mounted on a stem that is inserted into the femur;
- A part designed to replace the acetabulum: the acetabular cup. There are single-mobility cups and double-mobility cups, where an insert is positioned on the metal head inside a single-mobility cup. Introduced in the 1960s by Sir John Charnley, UHMWPE (Ultra High Molecular Weight Polyethylene) remains the most widely used material for inserts in 2024.
The NJR has observed that between 10 and 20% of hip implants require revision within the first 10 years. The main reasons for these revisions include implant fractures, joint incompatibility, aseptic loosening, dislocation and wear of the polyethylene (PE) insert.
To address this problem, highly cross-linked polyethylene (HXLPE) inserts have been developed. Cross-linking helps to limit wear on polyethylene prostheses in total hip arthroplasty. However, there are concerns about the loss of elasticity of HXLPE and oxidation after implantation.
A new generation of inserts based on highly cross-linked polyethylene (irradiation dose ≥100 Kgy), enriched with vitamin E, has been developed. This PE, called ECIMA, was developed to maintain mechanical properties, minimise PE wear and improve long-term oxidation resistance.
In the HAS evaluation report on highly cross-linked polyethylene inserts dated 24 January 2023, data from the literature show less wear of highly cross-linked polyethylene compared to conventional polyethylene.
Nevertheless, the use of highly cross-linked polyethylene is not yet the gold standard. Furthermore, the data in the literature mainly concern single-mobility cups but not double-mobility cups. Finally, new imaging protocols now make it possible to assess the wear of prosthesis materials more accurately.
In this context, it seems appropriate to conduct a French study comparing double-mobility cups containing highly cross-linked polyethylene or conventional polyethylene inserts.
In the principal investigator's current practice, prostheses with conventional PE inserts are used for patients aged 70 or over, while prostheses with highly cross-linked PE inserts are used for patients under 70. However, this age-based choice is modulated favourably or unfavourably by two other parameters: the patient's medical history and general condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Highly cross-linked PE | Experimental | Device: ECIMA CORINThe hip prosthesis will be a MOBILIT acetabular cup (Corin), MEIJE femoral stem (Corin), 28 mm diameter metal ball (Corin), and mobile cup (Corin) made of highly cross-linked PE doped with vitamin E (ECIMA, Corin). |
| Conventional PE | Active comparator | Device: CORINThe hip prosthesis will be a MOBILIT (Corin) acetabular prosthesis, MEIJE (Corin) femoral stem, 28 mm diameter metal ball (Corin), and mobile cup (Corin) in conventional PE. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient, male or female, aged between 55 and 80.
- Patient with a life expectancy > 5 years at the time of inclusion.
- Patient scheduled to undergo primary total hip arthroplasty with a dual-mobility cup prosthesis.
- Patient affiliated with or beneficiary of a social security scheme.
- Patient who speaks French and has signed an informed consent form.
Key exclusion criteria (4 listed)
- Patients with a contraindication mentioned in the instructions for use of the medical device under investigation
- Patients with an ASA score of 4
- Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision
- Patients participating in another clinical study whose objectives could interfere with this 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 |
|---|---|---|
| ECIMA CORINMobile cup (Corin) made of highly cross-linked PE doped with vitamin E (ECIMA, Corin). | Device | Highly cross-linked PE |
| CORINMobile cupule (Corin) is made of conventional PE | Device | Conventional PE |
Primary outcome
Femoral head penetration into the acetabulum
Time frame: Year 5
Femoral head penetration into the acetabulum will be measured in mm/year, based on a hip X-ray and PolyWare® software, Rev 8, Draftware Inc, North Webster, IN, USA
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 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Hip Arthroplasty Replacement
Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness
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 ECIMA CORIN and CORIN in people with Hip Arthroplasty Replacement, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 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 20 Aug 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 JEAN LANGLOIS, MD (+ 33 6 03 29 45 33, jeangast@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral head penetration into the acetabulum (time frame: Year 5). 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 20 Aug 2026.