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NCT Number: NCT06511856

FH ORTHO Shoulder Observatory

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.

Recruiting

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Key information

Conditions

Trauma Arthropathy Shoulder Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique VIA DOMITIA, Lunel, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Patient unable to participate in the study and/or complete the questionnaires 2. Refusal of patient participation

Treatment and study plan

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.

Other names: ARROW II, Telegraph Evolution, STRAPFLEX

Primary outcomes

Performance of the medical devices over long term follow-up (maximum10 years)

Time frame: maximum 10 years

Functional performance measured by the Constant-Murley score

Secondary outcomes

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

Time frame: maximum 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Cédric FERRY

CONTACT

[email protected]

+33 (0)6 49 63 78 29

Stéphanie LHUILLIER

CONTACT

[email protected]

+33 (0)6 07 34 59 65

Sponsors and collaborators

Lead sponsor

FH ORTHO

Industry

Registry information

Official study title

Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices

Important dates

Study start: 2022
Primary completion: 2032
Study completion: 2035
First posted: Jul 22, 2024
Registry last updated: Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting