TraumaNCT06511856
FH ORTHO Shoulder Observatory
An observational study of Trauma and Arthropathy Shoulder, run by FH ORTHO at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Arthropathy Shoulder
- What is being tested?
- ARROW
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Sep 2022to 8 Sep 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient considered for implantation or use of medical devices for shoulder arthroplasty and traumatology distributed by FH ORTHO SAS.
Who may be able to join
- 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.
Who cannot join
- 1. Patient unable to participate in the study and/or complete the questionnaires 2. Refusal of patient participation
- -
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Clinique VIA DOMITIA
Lunel, 34400
Omar NAJI, Dr, +33 (0) 4 67 91 18 05
- Recruiting
Clinique Bizet
Paris, 75116
Philippe VALENTI, Dr, +33 (0) 184 130 454
- Recruiting
Clinique de l'Union
Saint-Jean, 31243
Jean KANY, Dr, +33 (0)5.61.37.87.47
About this study
Official title: 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.
Read more
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
- Being tested
- ARROW
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARROWDevice
Also called ARROW II, Telegraph Evolution, STRAPFLEX
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.
| Study group | Role | What they receive |
|---|---|---|
| FH ORTHO shoulder patients | Patients operated with FH ORTHO shoulder medical devices (arthroplasty and trauma) Receives: Device: ARROW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the medical devices over long term follow-up (maximum10 years)
Functional performance measured by the Constant-Murley score
Measured: maximum 10 years
Secondary outcomes (1)
revision rate medical devices over long term follow-up (maximum10 years)
Measured: maximum 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start8 Sep 2022
- Primary completion8 Sep 2032 (estimated)
- Study completion8 Sep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FH ORTHO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511856
- Sponsor's protocol ID
- 2020-03
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices
- ClinicalTrials.gov ID
- NCT06511856
- Acronym / sponsor ID
- 2020-03
- Conditions
- Trauma, Arthropathy Shoulder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- FH ORTHOIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 8 Sep 2032 (estimated)
- Study completion
- 8 Sep 2035 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FH ORTHO shoulder patients | – | Device: ARROWPatients operated with FH ORTHO shoulder medical devices (arthroplasty and trauma) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient considered for implantation or use of medical devices for shoulder arthroplasty and traumatology distributed by FH ORTHO SAS.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 1. Patient unable to participate in the study and/or complete the questionnaires 2. Refusal of patient participation
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARROWAlso: ARROW II, Telegraph Evolution, STRAPFLEXPatients 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. | Device | FH ORTHO shoulder patients |
Primary outcome
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
1 secondary outcome
revision rate medical devices over long term follow-up (maximum10 years)
Time frame: maximum 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Arthropathy Shoulder, run by FH ORTHO at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cédric FERRY (+33 (0)6 49 63 78 29, c.ferry@fhortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the medical devices over long term follow-up (maximum10 years) (time frame: maximum 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.