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Recruiting

NCT Number: NCT05966220

Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.

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).

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Pasteur, Guilherand-Granges, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Drug dependency.
  • Uncooperative patient unable to follow recommendations.
  • Protected adult

Treatment and study plan

Hip surgery with FH Ortho devices

Device

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.

Primary outcomes

  1. Survival rate (revision) of the medical device over the long term (maximum 15 years).

    Time frame: maximum 15 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent GAUDIOT, MD

CONTACT

[email protected]

+33 2 40 95 92 81

Sponsors and collaborators

Lead sponsor

FH ORTHO

Industry

Registry information

Official study title

Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices (FH ORTHO Company Hip Observatory).

Acronym: HipFHOrtho

Important dates

Study start
2024
Primary completion
2038
Study completion
2038
First posted
Jul 28, 2023
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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