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

NCT05966220 | Recruiting

• 1 other identifier: 2021-01
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Hip Surgery

Keywords

hip prosthesis, observatory

Outcome Measures

Primary Outcomes (1)

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

  maximum 15 years.

Study Arms (2)

Total hip arthroplasty (THA) and Revision THA

OTHER

Patients will be monitored for up to 15 years postoperatively.

Device: Hip surgery with FH Ortho devices

Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty

OTHER

Patients will be monitored for up to 10 years postoperatively.

Device: Hip surgery with FH Ortho devices

Interventions

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.

Total hip arthroplasty (THA) and Revision THA; Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• FH ORTHO: lead

Study Sites (5)

Clinique Pasteur

Guilherand-Granges, 07 500, France

RECRUITING

Centre Hospitalier Du Haut Bugey

Oyonnax, 01 100, France

RECRUITING

Polyclinique Reims-Courlancy

Reims, 51 100, France

RECRUITING

Clinique Mutualiste La Sagesse

Rennes, 35 043, France

RECRUITING

Clinique de l'Atlantique

Saint-Herblain, 44 800, France

RECRUITING

Central Study Contacts

Vincent GAUDIOT, MD

CONTACT

+33 2 40 95 92 81; vincent.gaudiot@wanadoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 28, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): December 1, 2038
• Study Completion (Estimated): December 1, 2038
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)