NCT05966220

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: FH ORTHO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Hip surgery with FH Ortho devices	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.

Timeline

• Start date: 2024-01-08
• Primary completion: 2038-12-01
• Completion: 2038-12-01
• First posted: 2023-07-28
• Last updated: 2026-02-02

Locations

5 sites across 1 country: France