NCT06511856

FH ORTHO Shoulder Observatory

Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: FH ORTHO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma
• Arthropathy Shoulder

Interventions

Type	Name	Description
DEVICE	ARROW	Patients included in the study are patients operated with one or more shoulder medical device fabricated by FH ORTHO. Medical devices of interest are CE marked and include ARROW and ARROW prosthesis, Telegraph Evolution humeral nail and STRAPFLEX strapping system.

Timeline

• Start date: 2022-09-08
• Primary completion: 2032-09-08
• Completion: 2035-09-08
• First posted: 2024-07-22
• Last updated: 2024-07-22

Locations

3 sites across 1 country: France

Regulatory

• FDA-regulated device study