Hip ArthropathyICARENCT05175300
Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
A study testing Prosthesis with CoPXE couple. and Prosthesis with CoC torque. in people with Hip Arthropathy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- Prosthesis with CoPXE couple. and Prosthesis with CoC torque.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2023to Mar 2032
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 to 65 years,
- Who have signed their consent to participate in the study,
- For whom an indication for total hip arthroplasty has been given
Who cannot join
- History of hip surgery
- Indication for a dual mobility prosthesis (obese patient, dynamic spino-pelvic anomaly)
- Hip dysplasia
- Inflammatory rheumatic disease or any other progressive concomitant condition that may impact the patient's vital or functional prognosis
- Sequelae of neurological disease or stroke
- Pregnant or breastfeeding women
Show all 10Show fewer
- Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
- Patient likely not to return for follow-up visits
- Patient already included in another therapeutic study protocol
- Patient under court protection, guardianship or curatorship.
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, 69008
Jean LANGLOIS, MD, 0603294533 ext. 33, jeangast@gmail.com
Jean LANGLOIS, MD
About this study
Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.
Read the detailed description
A single-centre, prospective, randomised, single-blind, comparative study of two parallel groups of patients undergoing total hip arthroplasty:
- Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
- Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.
- Conditions
- Hip Arthropathy
- Being tested
- Prosthesis with CoPXE couple., Prosthesis with CoC torque.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthesis with CoPXE couple.Device
Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
Prosthesis with CoC torque.Device
Prosthesis with ceramic-on-ceramic (CoC) torque.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple. Receives: Device: Prosthesis with CoPXE couple. |
| Group 2 | Active comparator | Prosthesis with ceramic-on-ceramic (CoC) torque. Receives: Device: Prosthesis with CoC torque. |
What is being measured
The primary outcome is the main question the study is designed to answer.
five-year wear thickness of the two friction pairs
The primary endpoint is the five-year wear thickness of the two friction pairs (CoPXE versus CoC) after total hip arthroplasty. Wear thickness is the measurement of the penetration of the femoral head into the acetabular component. This measurement will be performed on frontal pelvic radiographs centred on the pubic symphysis using the semi-automatic computer-assisted technique described by Martell
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 Jan 2022
- Study start24 Mar 2023
- Primary completionMar 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-centre, prospective, randomised, single-blind, comparative, category 2 study of two parallel groups of patients undergoing total hip arthroplasty: * Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple. * Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175300
- Sponsor's protocol ID
- 2021-A02040-41
- Acronym
- ICARE
- Status last verified
- Nov 2025
- First submitted
- 14 Dec 2021
- Last updated
- 3 Dec 2025
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
- ClinicalTrials.gov ID
- NCT05175300
- Acronym / sponsor ID
- ICARE / 2021-A02040-41
- Conditions
- Hip Arthropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 3 Jan 2022 (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.
Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.
Detailed description
A single-centre, prospective, randomised, single-blind, comparative study of two parallel groups of patients undergoing total hip arthroplasty:
- Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
- Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A single-centre, prospective, randomised, single-blind, comparative, category 2 study of two parallel groups of patients undergoing total hip arthroplasty: * Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple. * Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Prosthesis with CoPXE couple.Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple. |
| Group 2 | Active comparator | Device: Prosthesis with CoC torque.Prosthesis with ceramic-on-ceramic (CoC) torque. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 18 to 65 years,
- Who have signed their consent to participate in the study,
- For whom an indication for total hip arthroplasty has been given
Key exclusion criteria (10 listed)
- History of hip surgery
- Indication for a dual mobility prosthesis (obese patient, dynamic spino-pelvic anomaly)
- Hip dysplasia
- Inflammatory rheumatic disease or any other progressive concomitant condition that may impact the patient's vital or functional prognosis
- Sequelae of neurological disease or stroke
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 |
|---|---|---|
| Prosthesis with CoPXE couple.Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple. | Device | Group 1 |
| Prosthesis with CoC torque.Prosthesis with ceramic-on-ceramic (CoC) torque. | Device | Group 2 |
Primary outcome
five-year wear thickness of the two friction pairs
Time frame: Year 5
The primary endpoint is the five-year wear thickness of the two friction pairs (CoPXE versus CoC) after total hip arthroplasty. Wear thickness is the measurement of the penetration of the femoral head into the acetabular component. This measurement will be performed on frontal pelvic radiographs centred on the pubic symphysis using the semi-automatic computer-assisted technique described by Martell
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 3 Dec 2025.
- 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 Prosthesis with CoPXE couple. and Prosthesis with CoC torque. in people with Hip Arthropathy, 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 3 inclusion and 10 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 3 Dec 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 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 (0603294533 ext. 33, jeangast@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
five-year wear thickness of the two friction pairs (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 3 Dec 2025.