FH ORTHO Shoulder Observatory

NCT06511856 | Recruiting FDA Device

• 1 other identifier: 2020-03
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

Trauma; Arthropathy Shoulder

Outcome Measures

Primary Outcomes (1)

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

  Functional performance measured by the Constant-Murley score

  maximum 10 years

Secondary Outcomes (1)

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

  maximum 10 years

Study Arms (1)

FH ORTHO shoulder patients

Patients operated with FH ORTHO shoulder medical devices (arthroplasty and trauma)

Device: ARROW

Interventions

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.

Also known as: ARROW II, Telegraph Evolution, STRAPFLEX

FH ORTHO shoulder patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• FH ORTHO: lead

Study Sites (3)

Clinique VIA DOMITIA

Lunel, 34400, France

RECRUITING

Clinique Bizet

Paris, 75116, France

RECRUITING

Clinique de l'Union

Saint-Jean, 31243, France

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Cédric FERRY

CONTACT

+33 (0)6 49 63 78 29; c.ferry@fhortho.com

Stéphanie LHUILLIER

CONTACT

+33 (0)6 07 34 59 65; s.lhuillier@fhortho.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 22, 2024
• Study Start: September 8, 2022
• Primary Completion (Estimated): September 8, 2032
• Study Completion (Estimated): September 8, 2035
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

FR (3)