Observing long-term outcomes of shoulder joint replacements and repairs
Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices
This study is looking to see how well shoulder joint replacements and repairs work for patients over 5 to 10 years after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fh Ortho Industry-sponsored |
| Locations | 3 sites (Lunel and 2 other locations) |
| Trial ID | NCT06511856 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing shoulder arthroplasty or trauma repair with FH ORTHO SAS devices.
Not a fit: Patients who are unable to participate in the study or complete the required questionnaires will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of shoulder joint replacement devices.
How similar studies have performed: Other observational studies have successfully documented long-term outcomes for similar orthopedic interventions, indicating a potential for valuable findings in this area.
Eligibility criteria
Show full inclusion / exclusion 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 \-
Where this trial is running
Lunel and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.