Hip ArthropathyNCT04993638
Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE
An observational study of Hip Arthropathy and Hip Osteoarthritis, run by EUROS at 3 sites in France.
Trial summary
EUROSCUP MOBILE is intended for use in primary and revision total hip replacement surgery. Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Arthropathy, Hip Osteoarthritis, Hip Arthritis
- What is being tested?
- hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 147 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jun 2021to Jun 2034
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who fulfill the criteria of eligilibilty according to the instructions for use of EUROSCUP MOBILE
Who may be able to join
- Patient who received EUROSCUP MOBILE.
- Patient informed of its participation to the study
- Patient aged between 18 and 80 years old (<80).
Who cannot join
- Patient presenting a contraindication to EUROSCUP MOBILE implantation.
- Patient who refused to participate to the study
- Vulnerable subjects
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinique Montagard
Avignon, 84000
CHU Gabriel Montpied
Clermont-Ferrand, 63000
Hôpital Saint Joseph-Saint Luc
Lyon, 69007
About this study
EUROSCUP MOBILE is intended for use in primary and revision total hip replacement surgery.
Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
As part of post market vigilance, EUROS will collect data on EUROSCUP MOBILE performances and safety
Read the detailed description
Post market observational study. This study is retropective and prospective, non comparative.
- Conditions
- Hip Arthropathy, Hip Osteoarthritis, Hip Arthritis, Hip Fractures, Hip Necrosis, Hip Dysplasia
- Being tested
- hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip, Hip Fractures, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip arthroplastyDevice
Hip prosthesis surgery
| Study group | Role | What they receive |
|---|---|---|
| EUROSCUP MOBILE cementless | 107 who received cementless version of EUROSCUP MOBILE Receives: Device: hip arthroplasty | |
| EUROSCUP MOBILE cemented | 40 who received cemented version of EUROSCUP MOBILE Receives: Device: hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of EUROSCUP MOBILE
Collect the safety of the device trought complications occurence rate
Measured: 1 year
Secondary outcomes (3)
Radiological performances of EUROSCUP MOBILE
Collect the performances of the device trought radiological evaluation
Measured: 1 year
Clinical performances of EUROSCUP MOBILE
Collect the performances of the device trought clinical scores
Measured: 1 year
Survival of EUROSCUP MOBILE
Assess the survival rate of the device
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2034 (estimated)
- Study completionJun 2034 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- EUROS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993638
- Sponsor's protocol ID
- EC-310-02-01-A
- Status last verified
- Aug 2024
- First submitted
- 4 Jun 2021
- Last updated
- 28 Aug 2024
- 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 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE
- ClinicalTrials.gov ID
- NCT04993638
- Acronym / sponsor ID
- EC-310-02-01-A
- Conditions
- Hip Arthropathy, Hip Osteoarthritis, Hip Arthritis, Hip Fractures, Hip Necrosis, Hip Dysplasia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 147 participants (actual)
- Lead sponsor
- EUROSIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2034 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 6 Aug 2021 (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.
EUROSCUP MOBILE is intended for use in primary and revision total hip replacement surgery.
Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
As part of post market vigilance, EUROS will collect data on EUROSCUP MOBILE performances and safety
Detailed description
Post market observational study. This study is retropective and prospective, non comparative.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUROSCUP MOBILE cementless | – | Device: hip arthroplasty107 who received cementless version of EUROSCUP MOBILE |
| EUROSCUP MOBILE cemented | – | Device: hip arthroplasty40 who received cemented version of EUROSCUP MOBILE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who fulfill the criteria of eligilibilty according to the instructions for use of EUROSCUP MOBILE
Key inclusion criteria (3 listed)
- Patient who received EUROSCUP MOBILE.
- Patient informed of its participation to the study
- Patient aged between 18 and 80 years old (<80).
Key exclusion criteria (3 listed)
- Patient presenting a contraindication to EUROSCUP MOBILE implantation.
- Patient who refused to participate to the study
- Vulnerable subjects
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 |
|---|---|---|
| hip arthroplastyHip prosthesis surgery | Device | EUROSCUP MOBILE cemented, EUROSCUP MOBILE cementless |
Primary outcome
Safety of EUROSCUP MOBILE
Time frame: 1 year
Collect the safety of the device trought complications occurence rate
3 secondary outcomes
Radiological performances of EUROSCUP MOBILE
Time frame: 1 year
Clinical performances of EUROSCUP MOBILE
Time frame: 1 year
Survival of EUROSCUP MOBILE
Time frame: 10 year
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 Aug 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthropathy and Hip Osteoarthritis, run by EUROS at 3 sites 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 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of EUROSCUP MOBILE (time frame: 1 year). 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 28 Aug 2024.