An observational study in Trauma and Arthropathy Shoulder, sponsored by FH ORTHO. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by FH ORTHO · Observational
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 216 observational studies indexed under Joint Diseases.
Browse Joint Diseases studies →FH ORTHO is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Any patient considered for implantation or use of medical devices for shoulder arthroplasty and traumatology distributed by FH ORTHO SAS.
Exclusion criteria:
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Patients operated with FH ORTHO shoulder medical devices (arthroplasty and trauma)
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.
Also known as: ARROW II, Telegraph Evolution, STRAPFLEX
Performance of the medical devices over long term follow-up (maximum10 years)
Functional performance measured by the Constant-Murley score
Time frame: maximum 10 years
revision rate medical devices over long term follow-up (maximum10 years)
Time frame: maximum 10 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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