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

Hip Surgery Clinical Trial

— HipFHOrtho  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05966220
• Other study ID #: 2021-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2038

Study information

• Verified date: November 2023
• Source: FH ORTHO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 2038
• Est. primary completion date: December 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Surgery

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
FH ORTHO

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate (revision) of the medical device over the long term (maximum 15 years).		maximum 15 years.