FH ORTHO Shoulder Observatory

ConditionsTrauma Arthropathy Shoulder

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorFH ORTHO

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Any patient considered for implantation or use of medical devices for shoulder arthroplasty and traumatology distributed by FH ORTHO SAS.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

ARROW
Device
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.

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: FH ORTHO shoulder patients1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

revision rate medical devices over long term follow-up (maximum10 years)

Time frame

maximum 10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

FH ORTHO

Lead sponsor

Source ClinicalTrials.gov

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