| NCT ID | NCT06511856 |
| Status | Recruiting |
| Phase | — |
| Sponsor | FH ORTHO |
| Condition | Trauma |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-09-08 |
| Primary Completion | 2032-09-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-09-08 with a primary completion date of 2032-09-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06511856 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06511856 currently recruiting?
Yes, NCT06511856 is actively recruiting participants. Contact the research team at c.ferry@fhortho.com for enrollment information.
Where is the NCT06511856 trial being conducted?
This trial is being conducted at Lunel, France, Paris, France, Saint-Jean, France.
Who is sponsoring the NCT06511856 clinical trial?
NCT06511856 is sponsored by FH ORTHO. The trial plans to enroll 500 participants.