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Recruiting NCT06511856

FH ORTHO Shoulder Observatory

— Observational Trauma Arthropathy Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARROW.
Who it may be relevant to
Registry conditions: Trauma, Arthropathy Shoulder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices

Overview

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.

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.

Primary outcome measures

  • Performance of the medical devices over long term follow-up (maximum10 years) [Time frame: maximum 10 years]
Secondary outcome measures (1)
  • revision rate medical devices over long term follow-up (maximum10 years) [Time frame: maximum 10 years]

Eligibility criteria

Inclusion criteria

  • 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)
  • Patient is at least 18 years of age
  • 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

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • Clinique VIA DOMITIA — Lunel
  • Clinique Bizet — Paris
  • Clinique de l'Union — Saint-Jean

Identifiers

NCT: NCT06511856 · 2020-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗