Observing long-term outcomes of shoulder joint replacements and repairs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair due to trauma. It focuses on documenting the benefits and risks associated with medical devices distributed by FH ORTHO SAS, used in routine surgical settings. The study will follow patients for 5 to 10 years to gather real-life data on their outcomes, ensuring compliance with post-market clinical follow-up requirements. Participation is open to patients undergoing these procedures at designated centers.

Why it matters

Who can join: the full rules

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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Where it's running

• Clinique VIA DOMITIA
  Lunel, France Recruiting
• Clinique Bizet
  Paris, France Recruiting
• Clinique de l'Union
  Saint-Jean, France Recruiting

Study contacts

• Study coordinator: Cédric FERRY
• Email: c.ferry@fhortho.com
• Phone: +33 (0)6 49 63 78 29

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.