FH ORTHO Shoulder Observatory

Launched by FH ORTHO · Jul 15, 2024

Keywords

ClinConnect Summary

The FH ORTHO Shoulder Observatory is a clinical study designed to gather important long-term information about patients who have had shoulder joint replacement or repair surgery due to trauma. This study will help doctors understand how well certain medical devices work over time and ensure they are safe for patients. It will follow participants for 5 to 10 years to see how they recover and how these devices perform in real-life situations.

To join this study, participants must be at least 18 years old and undergoing surgery that involves specific medical devices from FH ORTHO SAS. They need to agree to participate after learning about the study and giving their consent. Patients who cannot fill out questionnaires or who choose not to take part will not be included. This study is currently recruiting participants of all genders and aims to gather data from a large number of people to enhance our understanding of shoulder treatments.

Gender

ALL

Eligibility criteria

• 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
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