Actively Recruiting
Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.
Led by FH ORTHO · Updated on 2026-02-02
800
Participants Needed
5
Research Sites
777 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient undergoing or having undergone hip arthroplasty or trauma repair with FH ORTHO Company medical devices used according to approved instructions at a participating center
- Patient is at least 18 years old
- Patient agrees to participate after being informed and provides consent if required
- Patient is socially insured if required by local country regulations (e.g., France)
You will not qualify if you...
- Presence of infection or latent infection
- Mental or neuromuscular disorder causing unacceptable risk to prosthesis stability or healing (except specific approved device combinations)
- Known poor bone quality or insufficient bone stock
- Known allergy to any device material components
- Metabolic diseases that impair bone regrowth
- Metabolic or vascular diseases or treatments affecting bone healing
- Drug dependency
- Patient unable or unwilling to follow recommendations
- Patient is a protected adult
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Clinique Pasteur
Guilherand-Granges, France, 07 500
Actively Recruiting
2
Centre Hospitalier Du Haut Bugey
Oyonnax, France, 01 100
Actively Recruiting
3
Polyclinique Reims-Courlancy
Reims, France, 51 100
Actively Recruiting
4
Clinique Mutualiste La Sagesse
Rennes, France, 35 043
Actively Recruiting
5
Clinique de l'Atlantique
Saint-Herblain, France, 44 800
Actively Recruiting
Research Team
V
Vincent GAUDIOT, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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