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

FH ORTHO

Status: Enrolling

Conditions: Hip Surgery

Treatments: Device: Hip surgery with FH Ortho devices

Study type: Interventional

Funder types: Industry

Identifiers

NCT05966220

2021-01

Details and patient eligibility

About

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).

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Total hip arthroplasty (THA) and Revision THA

Other group

Description:

Patients will be monitored for up to 15 years postoperatively.

Treatment:

Device: Hip surgery with FH Ortho devices

Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty

Other group

Description:

Patients will be monitored for up to 10 years postoperatively.

Treatment:

Device: Hip surgery with FH Ortho devices