Hip OsteoarthritisNCT04995822
Post Market Clinical Follow-up of EUROSTEM Femoral Stem
An observational study of Hip Osteoarthritis and Hip Arthropathy, run by EUROS at 9 sites in France.
Trial summary
EUROSSTEM 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 years and older
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthropathy, Hip Arthritis
- What is being tested?
- hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 131 participants
- Where
- 9 sitesFrance
- Study dates
- 21 May 2021to 6 Nov 2032
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who fulfill the criteria of eligilibilty according to the instructions for use of EUROSTEM
Who may be able to join
- Patient who received EUROSTEM
- Patient informed of its participation to the study
- Patient aged over 18 to date of surgery
Who cannot join
- Patient presenting a contraindication to EUROSTEM implantation.
- Patient who refused to participate to the study
- Vulnerable subjects
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Clinique Esquirol St Hilaire
Agen, 47000
CH Aix en Provence
Aix-en-Provence, 13100
Polyclinique du Beaujolais
Arnas, 69400
Clinique Montagard
Avignon, 84000
Polyclinique du Parc Drevon
Dijon, 21000
Clinique du Palais
Grasse, 06130
Hôpital privé Drôme Ardèche - Clinique Pasteur
Guilherand-Granges, àè(àà
Clinique du Mail
Puilboreau, La Rochelle, 17138
Clinique Richelieu
Saintes, 17100
About this study
EUROSSTEM 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 EUROSTEM performances and safety
Read the detailed description
Post market observational study. This study is multicenter, prospective, non comparative.
- Conditions
- Hip Osteoarthritis, Hip Arthropathy, Hip Arthritis, Hip Necrosis, Hip Fractures, 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 |
|---|---|---|
| EUROSTEM femoral stem | All patients who received EUROSTEM femoral stem whatever the version (cemented or cementless) Receives: Device: hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of EUROSTEM Femoral Stem
Collect the safety of the device trought complications occurence rate
Measured: 1 year
Secondary outcomes (3)
Radiological performances of EUROSTEM Femoral Stem
Collect the performances of the device trought radiological evaluation
Measured: 1 year
Clinical performances of EUROSTEM Femoral Stem
Collect the performances of the device trought clinical scores
Measured: 1 year
Survival of EUROSTEM Femoral Stem
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 posted9 Aug 2021
- Study start21 May 2021
- Primary completion6 Nov 2022
- Study completion6 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EUROS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995822
- Sponsor's protocol ID
- EC-309-01
- Status last verified
- Feb 2024
- First submitted
- 30 Jul 2021
- Last updated
- 20 Feb 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up of EUROSTEM Femoral Stem
- ClinicalTrials.gov ID
- NCT04995822
- Acronym / sponsor ID
- EC-309-01
- Conditions
- Hip Osteoarthritis, Hip Arthropathy, Hip Arthritis, Hip Necrosis, Hip Fractures, Hip Dysplasia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- EUROSIndustry (pharma, biotech, devices)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 6 Nov 2022 (actual)
- Study completion
- 6 Nov 2032 (estimated)
- First posted
- 9 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.
EUROSSTEM 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 EUROSTEM performances and safety
Detailed description
Post market observational study. This study is multicenter, prospective, non comparative.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUROSTEM femoral stem | – | Device: hip arthroplastyAll patients who received EUROSTEM femoral stem whatever the version (cemented or cementless) |
Who may qualify
- Ages
- 18 years and older
- 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 EUROSTEM
Key inclusion criteria (3 listed)
- Patient who received EUROSTEM
- Patient informed of its participation to the study
- Patient aged over 18 to date of surgery
Key exclusion criteria (3 listed)
- Patient presenting a contraindication to EUROSTEM 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 | EUROSTEM femoral stem |
Primary outcome
Safety of EUROSTEM Femoral Stem
Time frame: 1 year
Collect the safety of the device trought complications occurence rate
3 secondary outcomes
Radiological performances of EUROSTEM Femoral Stem
Time frame: 1 year
Clinical performances of EUROSTEM Femoral Stem
Time frame: 1 year
Survival of EUROSTEM Femoral Stem
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 20 Feb 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.
9 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 Osteoarthritis and Hip Arthropathy, run by EUROS at 9 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 EUROSTEM Femoral Stem (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 20 Feb 2024.