FH ORTHO Shoulder Observatory

Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma; Arthropathy Shoulder
• Intervention / Treatment: Device: ARROW

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Cédric FERRY; Phone Number: +33 (0)6 49 63 78 29; Email: c.ferry@fhortho.com
• Study Contact Backup: Name: Stéphanie LHUILLIER; Phone Number: +33 (0)6 07 34 59 65; Email: s.lhuillier@fhortho.com

Study Locations

• France
  • Lunel, France, 34400
    • Recruiting
    • Clinique Via Domitia
    • Contact: Omar NAJI, Dr; Phone Number: +33 (0) 4 67 91 18 05
  • Paris, France, 75116
    • Recruiting
    • Clinique Bizet
    • Contact: Philippe VALENTI, Dr; Phone Number: +33 (0) 184 130 454
  • Saint-Jean, France, 31243
    • Recruiting
    • Clinique de l'Union
    • Contact: Jean KANY, Dr; Phone Number: +33 (0)5.61.37.87.47

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FH ORTHO shoulder patients; 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.; Other Names: ARROW II; Telegraph Evolution; STRAPFLEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the medical devices over long term follow-up (maximum10 years)	Functional performance measured by the Constant-Murley score	maximum 10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
revision rate medical devices over long term follow-up (maximum10 years)	maximum 10 years

Collaborators and Investigators

• Sponsor: FH ORTHO

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Estimated): September 8, 2032
• Study Completion (Estimated): September 8, 2035

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2020-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No