Long-term follow-up after hip surgery with FH ORTHO implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This post-market clinical follow-up (PMCF) observatory gathers clinical data from adult patients receiving FH ORTHO devices for hip arthroplasty or trauma repair at participating centers. A dynamic cohort design allows new inclusions during the enrollment period and replacements for premature exits to maintain follow-up. Surgeons will record device models, implant combinations, and perioperative details in electronic case report forms, while clinical outcomes and complications are captured during routine visits. The registry aims to cover different device versions and combinations to monitor safety, performance, and residual risks under normal use and to meet local regulatory requirements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Patient is at least 18 years of age.
3. Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally).
4. In some countries, such as France, the patient will have to be socially insured to be included in the study.

Exclusion Criteria:

1. An infection, or latent infection.
2. 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).
3. Known Insufficient bone quality and/or bone stock.
4. Known allergy to any component of the material listed on the product label.
5. Metabolic diseases that could compromise bone regrowth.
6. Metabolic and/or vascular treatment or disease that may compromise bone healing or consolidation.
7. Drug dependency.
8. Uncooperative patient unable to follow recommendations.
9. Protected adult

Where it's running

• Clinique Pasteur
  Guilherand-Granges, France Recruiting
• Centre Hospitalier Du Haut Bugey
  Oyonnax, France Recruiting
• Polyclinique Reims-Courlancy
  Reims, France Recruiting
• Clinique Mutualiste La Sagesse
  Rennes, France Recruiting
• Clinique de l'Atlantique
  Saint-Herblain, France Recruiting

Study contacts

• Study coordinator: Vincent GAUDIOT, MD
• Email: vincent.gaudiot@wanadoo.fr
• Phone: +33 2 40 95 92 81

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.