Hip DiseaseESOP2NCT04193163
Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device
An observational study of Hip Disease and Hip Fractures, run by FH ORTHO at 7 sites in France.
Trial summary
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real life conditions according to the instructions for use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Disease, Hip Fractures
- What is being tested?
- Hip prosthesis - ESOP 2 cementless femoral stem
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Dec 2019to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients from participating hospitals will be enrolled as part of their clinical routine care.
Who may be able to join
- Subject implanted with ESOP 2 stem in one of the following indication according to the instructions for use: hip disorders; femoral neck fracture
- Subject who received an information form and is willing to participate in the study
Who cannot join
- Contraindications described in the instructions for use
- Usual surgical contraindications
- Subject who is not able to express his/her non-opposition
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Clinique Tivoli Ducos
Bordeaux, 33000
Nouvelle Clinique Bel-Air
Bordeaux, 33000
CH Pasteur
Colmar, 68024
Clinique du Val d'Ouest
Écully, 69130
CH Raymond POINCARE
Garches, 92380
CH de Haguenau
Haguenau, 67504
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75651
About this study
Official title: Prospective Observational Clinical Study Conducted Over a 10-year Period on Patients Who Received the ESOP 2 Stem to Restore Joint Function, in Order to Confirm Security and Performance of the Device
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real life conditions according to the instructions for use.
Read the detailed description
The primary objective of this study is to evaluate the security of the ESOP 2 stem by calculating the survival rate up to 10 years of follow-up.
The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score and quality of life score up to 10 years of follow-up.
- Conditions
- Hip Disease, Hip Fractures
- Being tested
- Hip prosthesis - ESOP 2 cementless femoral stem
- Keywords
- Arthroplasty, Hip replacement
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip prosthesis - ESOP 2 cementless femoral stemDevice
ESOP 2 femoral stems are intended to be implanted in the femoral region during total hip arthroplasty in order to restore joint function.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving ESOP 2 stem | Not described Receives: Device: Hip prosthesis - ESOP 2 cementless femoral stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: 10 years post-op
Secondary outcomes (4)
Radiographies evaluation
Radiological results such as stability, osteointegration will be evaluated.
Measured: immediate post-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Rate of complications
All complications will be gathered during intervention and up to 10 years postoperatively.
Measured: per-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Functional outcomes such as pain, mobility
Functional outcomes will be determined by the Harris Hip score. This score ranges from 0 to 100, where, the higher the score, the better the patient outcome.
Measured: pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Quality of life evaluation
Quality of life will be determined by the OXFORD-12 score. This score ranges from 12 points to 60 points, where, the higher the score, the better the patient outcome.
Measured: pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Dec 2019
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Why it stopped: Discontinuation of the studied medical device on the market and not enough inclusion in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DiseaseStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- FH ORTHO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193163
- Sponsor's protocol ID
- 2018-37
- Acronym
- ESOP2
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2019
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Clinical Study Conducted Over a 10-year Period on Patients Who Received the ESOP 2 Stem to Restore Joint Function, in Order to Confirm Security and Performance of the Device
- ClinicalTrials.gov ID
- NCT04193163
- Acronym / sponsor ID
- ESOP2 / 2018-37
- Conditions
- Hip Disease, Hip Fractures
- Keywords
- Arthroplasty, Hip replacement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Discontinuation of the studied medical device on the market and not enough inclusion in the study.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- FH ORTHOIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 10 Dec 2019 (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.
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real life conditions according to the instructions for use.
Detailed description
The primary objective of this study is to evaluate the security of the ESOP 2 stem by calculating the survival rate up to 10 years of follow-up.
The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score and quality of life score up to 10 years of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving ESOP 2 stem | – | Device: Hip prosthesis - ESOP 2 cementless femoral stem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from participating hospitals will be enrolled as part of their clinical routine care.
Key inclusion criteria (2 listed)
- Subject implanted with ESOP 2 stem in one of the following indication according to the instructions for use: hip disorders; femoral neck fracture
- Subject who received an information form and is willing to participate in the study
Key exclusion criteria (3 listed)
- Contraindications described in the instructions for use
- Usual surgical contraindications
- Subject who is not able to express his/her non-opposition
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 prosthesis - ESOP 2 cementless femoral stemESOP 2 femoral stems are intended to be implanted in the femoral region during total hip arthroplasty in order to restore joint function. | Device | Patients receiving ESOP 2 stem |
Primary outcome
Survival rate
Time frame: 10 years post-op
4 secondary outcomes
Radiographies evaluation
Time frame: immediate post-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Rate of complications
Time frame: per-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Functional outcomes such as pain, mobility
Time frame: pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Quality of life evaluation
Time frame: pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Results and safety
The study was stopped early (reason given: Discontinuation of the studied medical device on the market and not enough inclusion in the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- 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.
7 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 Disease and Hip Fractures, run by FH ORTHO at 7 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 2 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: stopped early, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was stopped early (reason given: Discontinuation of the studied medical device on the market and not enough inclusion in the study.). Results are not available in the source record.
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?
Survival rate (time frame: 10 years post-op). 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 2 Feb 2026.