FH ORTHO Shoulder Observatory

Recruiting

• Conditions: Arthropathy Shoulder; Trauma
• Interventions: Device: ARROW

• Registration Number: NCT06511856
• Lead Sponsor: FH ORTHO

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-08
• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Primary Completion: 2032-09-08
• Study Completion: 2035-09-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FH ORTHO shoulder patients	ARROW	Patients operated with FH ORTHO shoulder medical devices (arthroplasty and trauma)

Primary Outcome Measures

Name	Time	Method
Performance of the medical devices over long term follow-up (maximum10 years)	maximum 10 years	Functional performance measured by the Constant-Murley score

Secondary Outcome Measures

Name	Time	Method
revision rate medical devices over long term follow-up (maximum10 years)	maximum 10 years

Trial Locations

Locations (3)

Clinique VIA DOMITIA; 🇫🇷 Lunel, France

Clinique de l'Union; 🇫🇷 Saint-Jean, France

Clinique Bizet; 🇫🇷 Paris, France