FH ORTHO Shoulder Observatory

FH ORTHO

Status: Enrolling

Conditions: Trauma; Arthropathy Shoulder

Treatments: Device: ARROW

Study type: Observational

Funder types: Industry

Identifiers

NCT06511856

2020-03

Details and patient eligibility

About

This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma.

In this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.

This study meets the requirement for post-market clinical follow-up (PMCF) as defined in the European Medical Device Regulation (MDR 2017/745).

It therefore involves collecting in real life, i.e. under the usual conditions of surgery and short and long-term patient follow-up, minimal clinical data that will make it possible to document the continued benefit/risk of the medical devices concerned.

This study is designed as a permanent long-term observatory, of a non-interventional nature, with the objective of having long-term follow-up data (5 to 10 years depending on the devices concerned) for a maximum number of patients included.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Any patient undergoing implantation of medical devices distributed by FH ORTHO SAS for shoulder arthroplasty and traumatology, used in accordance with their approved labelling, in one of the centres participating in the Observatory (retrospectively or prospectively)
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) In some countries, such as France, the patient will have to be socially insured to be included in the study.

Exclusion criteria

1. Patient unable to participate in the study and/or complete the questionnaires 2. Refusal of patient participation

Trial design

500 participants in 1 patient group

FH ORTHO shoulder patients

Description:

Patients operated with FH ORTHO shoulder medical devices (arthroplasty and trauma)

Treatment:

Device: ARROW