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FH ORTHO Shoulder Observatory

NCT06511856 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-07-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • FH ORTHO

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2032-09-08
Completion
2035-09-08
FDA Device
Yes

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06511856 on ClinicalTrials.gov