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

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

This follow-up will collect real-world safety and performance data on FH ORTHO hip implants in adults who receive them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 800 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fh Ortho (Industry-sponsored)
• Locations: 5 sites (Guilherand-Granges and 4 other locations)
• Trial ID: NCT05966220 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (18 years and older) who receive or have received FH ORTHO hip implants at participating centers and can provide informed consent are eligible candidates.

Not a fit: Patients with active or latent infection, known severe bone insufficiency, certain neuromuscular or mental disorders that increase prosthetic risk, or known allergy to device materials are excluded or unlikely to benefit.

Why it matters

Potential benefit: If successful, this effort could improve knowledge of long-term safety and performance of FH ORTHO hip implants and help detect device-related problems earlier.

How similar studies have performed: Similar post-market registries for hip implants have often provided useful safety signals and performance information, although results vary by device and study design.

Eligibility criteria

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 this trial is running

Guilherand-Granges and 4 other locations

• 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

Conditions Hip Surgery; hip prosthesis, observatory