Actively Recruiting
Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices (FH ORTHO Company Hip Observatory)
Led by FH ORTHO · Updated on 2026-02-02
800
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting real-life clinical data on patients who have had hip surgery using medical devices from FH ORTHO Company. This study, a Post-Market Clinical Follow-up (PMCF) observatory, aims to answer specific questions about the safety and performance of these devices when used as intended. It includes patients undergoing hip joint replacement or repair after trauma, covering different device versions and implant combinations. The study monitors patients who have had total hip arthroplasty, revision surgeries, or traumatology-related hip procedures using FH ORTHO devices. Patients will be followed for up to 15 years post-surgery to observe the devices' long-term outcomes. Data collection is facilitated through electronic case report forms completed by surgeons and electronic patient-reported outcomes via phone, tablet, or computer. Participants will provide consent and may be monitored through regular follow-up visits and data collection over many years. Researchers will review the survival rate of the medical devices, focusing on revision rates as the main outcome measure. The study includes ongoing monitoring for up to 10 or 15 years, depending on the patient's procedure, to gather comprehensive safety and performance information.
CONDITIONS
Brief 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...
- Any patient undergoing or having undergone implantation of medical devices distributed by FH ORTHO Company for hip arthroplasty and traumatology, used according to approved instructions, in participating centers.
- Patient is at least 18 years of age.
- Patient agrees to participate after being informed orally and in writing (written consent if required locally).
- In some countries, patient must be socially insured to join the study.
You will not qualify if you...
- Presence of an infection or latent infection.
- Mental or neuromuscular disorder posing unacceptable risk for prosthetic stability or post-op complications (except for certain cemented device combinations).
- Known insufficient bone quality or bone stock.
- Known allergy to any component listed on the product label.
- Metabolic diseases that might affect bone regrowth.
- Metabolic or vascular disease or treatment that could compromise bone healing.
- Drug dependency.
- Uncooperative patient unable to follow recommendations.
- Protected adult status.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to a few weeks post-surgery
Participants undergo hip surgery using FH ORTHO Company medical devices and receive immediate post-operative care.
Duration - Up to 15 years postoperatively
Participants are monitored for clinical outcomes and device survival after surgery.
Regular follow-up visits over many years
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
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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