Arthropathy Shoulder, Trauma
Conditions
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.
Interventions
DEVICEARROW
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
FH ORTHO
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the medical devices over long term follow-up (maximum10 years) | maximum 10 years | Functional performance measured by the Constant-Murley score |
Secondary
| Measure | Time frame |
|---|---|
| revision rate medical devices over long term follow-up (maximum10 years) | maximum 10 years |
Countries
France
Contacts
Primary ContactCédric FERRY
Backup ContactStéphanie LHUILLIER
Outcome results
None listed