What is this study trying to find out about hip surgery?

This study is collecting real-life data on patients who have undergone hip surgery using FH ORTHO Company medical devices. It aims to evaluate the long-term safety and performance of these devices during regular use. The sponsor, FH ORTHO, is gathering information to better understand device outcomes over many years.

Who may be eligible for this hip surgery clinical trial?

Adults aged 18 years or older who have had or will have hip surgery using FH ORTHO devices may be eligible. The study accepts all genders and requires participants to be able to consent and follow study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this hip surgery clinical trial?

Study-related care, including the use of the medical devices and all follow-up visits, is provided at no cost. However, personal travel expenses to the study sites may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05966220

Long-Term Follow-Up Study of Hip Surgery Using FH ORTHO Medical Devices to Monitor Safety and Performance

Led by FH ORTHO · Updated on 2026-02-02

800

Participants Needed

Research Sites

N/A

Total Duration

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 patients 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

Age: 18Years +

All Genders

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.

Research Team

Vincent GAUDIOT, MD

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Long-Term Follow-Up Study of Hip Surgery Using FH ORTHO Medical Devices to Monitor Safety and Performance

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria