Hip SurgeryHipFHOrthoNCT05966220
Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.
A study testing Hip surgery with FH Ortho devices in people with Hip Surgery, run by FH ORTHO at 5 sites in France.
Trial summary
The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Surgery
- What is being tested?
- Hip surgery with FH Ortho devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 5 sitesFrance
- Study dates
- 8 Jan 2024to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient undergoing or having undergone implantation of medical devices distributed by FH ORTHO Company for hip arthroplasty and traumatology, used in accordance with their approved Instruction For Use, in one of the centers participating in the Observatory.
- Patient is at least 18 years of age.
- Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally).
- In some countries, such as France, the patient will have to be socially insured to be included in the study.
Who cannot join
- An infection, or latent infection.
- A mental or neuromuscular disorder that would create an unacceptable risk of prosthetic instability, failure of prosthetic fixation, or post-operative complications (except for the HIP\&GO Double mobility cemented cup and, if applicable, the associated stems and heads when assembled together).
- Known Insufficient bone quality and/or bone stock.
- Known allergy to any component of the material listed on the product label.
- Metabolic diseases that could compromise bone regrowth.
- Metabolic and/or vascular treatment or disease that may compromise bone healing or consolidation.
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- Drug dependency.
- Uncooperative patient unable to follow recommendations.
- Protected adult
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Clinique Pasteur
Guilherand-Granges, 07 500
Franck CLADIERE, MD, +33 4 75 82 31 78, franck.cladiere@wanadoo.fr
- Recruiting
Centre Hospitalier Du Haut Bugey
Oyonnax, 01 100
Samir YOUSEF, MD, +33 4 74 73 10 30, s.yousef@orange.fr
- Recruiting
Polyclinique Reims-Courlancy
Reims, 51 100
Elyes FOURATI, MD, elyesfourati@gmail.com
- Recruiting
Clinique Mutualiste La Sagesse
Rennes, 35 043
Mohamad DBOUK, MD, mohamed.dbouk@hospigrandouest.fr
- Recruiting
Clinique de l'Atlantique
Saint-Herblain, 44 800
Vincent GAUDIOT, MD, +33 2 40 95 92 81, vincent.gaudiot@wanadoo.fr
About this study
Official title: Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices (FH ORTHO Company Hip Observatory).
The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling).
The difficulty of such an observatory is to be able to collect data on the different versions of the devices, on the different possible combinations of implants of an arthroplasty. The observatory must also be able to cover devices used in surgery to repair osteoarticular trauma.
Read more
The observatory will be based on the principle of a "dynamic" cohort during the inclusion period, i.e. with possible inclusions to replace the premature exits.
Technical solutions will be implemented to facilitate data collection from surgeons (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome (ePRO) on phone/tablet/computer).
- Conditions
- Hip Surgery
- Being tested
- Hip surgery with FH Ortho devices
- Keywords
- hip prosthesis, observatory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip surgery with FH Ortho devicesDevice
This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone hip joint replacement or repair following hip trauma.
In this type of intervention, one or more medical devices distributed by FH ORTHO Company may be used by surgeons.
| Study group | Role | What they receive |
|---|---|---|
| Total hip arthroplasty (THA) and Revision THA | Other | Patients will be monitored for up to 15 years postoperatively. Receives: Device: Hip surgery with FH Ortho devices |
| Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty | Other | Patients will be monitored for up to 10 years postoperatively. Receives: Device: Hip surgery with FH Ortho devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate (revision) of the medical device over the long term (maximum 15 years).
Measured: maximum 15 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start8 Jan 2024
- Primary completionDec 2038 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FH ORTHO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966220
- Sponsor's protocol ID
- 2021-01
- Acronym
- HipFHOrtho
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2023
- Last updated
- 2 Feb 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices (FH ORTHO Company Hip Observatory).
- ClinicalTrials.gov ID
- NCT05966220
- Acronym / sponsor ID
- HipFHOrtho / 2021-01
- Conditions
- Hip Surgery
- Keywords
- hip prosthesis, observatory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- FH ORTHOIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Dec 2038 (estimated)
- Study completion
- Dec 2038 (estimated)
- First posted
- 28 Jul 2023 (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.
The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling).
The difficulty of such an observatory is to be able to collect data on the different versions of the devices, on the different possible combinations of implants of an arthroplasty. The observatory must also be able to cover devices used in surgery to repair osteoarticular trauma.
The observatory will be based on the principle of a "dynamic" cohort during the inclusion period, i.e. with possible inclusions to replace the premature exits.
Technical solutions will be implemented to facilitate data collection from surgeons (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome (ePRO) on phone/tablet/computer).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total hip arthroplasty (THA) and Revision THA | Other | Device: Hip surgery with FH Ortho devicesPatients will be monitored for up to 15 years postoperatively. |
| Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty | Other | Device: Hip surgery with FH Ortho devicesPatients will be monitored for up to 10 years postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any patient undergoing or having undergone implantation of medical devices distributed by FH ORTHO Company for hip arthroplasty and traumatology, used in accordance with their approved Instruction For Use, in one of the centers participating in the Observatory.
- Patient is at least 18 years of age.
- Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally).
- In some countries, such as France, the patient will have to be socially insured to be included in the study.
Key exclusion criteria (9 listed)
- An infection, or latent infection.
- A mental or neuromuscular disorder that would create an unacceptable risk of prosthetic instability, failure of prosthetic fixation, or post-operative complications (except for the HIP\&GO Double mobility cemented cup and, if applicable, the associated stems and heads when assembled together).
- Known Insufficient bone quality and/or bone stock.
- Known allergy to any component of the material listed on the product label.
- Metabolic diseases that could compromise bone regrowth.
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 surgery with FH Ortho devicesThis study is a real-life observatory designed to collect long-term clinical data on patients who have undergone hip joint replacement or repair following hip trauma. In this type of intervention, one or more medical devices distributed by FH ORTHO Company may be used by surgeons. | Device | Total hip arthroplasty (THA) and Revision THA, Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty |
Primary outcome
Survival rate (revision) of the medical device over the long term (maximum 15 years).
Time frame: maximum 15 years.
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 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip surgery with FH Ortho devices in people with Hip Surgery, run by FH ORTHO at 5 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 4 inclusion and 9 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 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 5 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?
Contact Vincent GAUDIOT, MD (+33 2 40 95 92 81, vincent.gaudiot@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (revision) of the medical device over the long term (maximum 15 years). (time frame: maximum 15 years.). 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.