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

NCT ID: NCT05966220

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2038-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Total hip arthroplasty (THA) and Revision THA

Patients will be monitored for up to 15 years postoperatively.

Group Type: OTHER

Hip surgery with FH Ortho devices

Intervention Type: 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.

Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty

Patients will be monitored for up to 10 years postoperatively.

Group Type: OTHER

Hip surgery with FH Ortho devices

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FH ORTHO

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2021-01

Identifier Type: -

Identifier Source: org_study_id