Humeral Fracture, ProximalNCT07558590
RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
An observational study of Humeral Fracture, Proximal and Glenohumeral Osteoarthritis, run by FX Solutions at 22 sites in 2 countries.
Trial summary
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS. The included cases will be followed for 10 years after index surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humeral Fracture, Proximal, Glenohumeral Osteoarthritis, Avascular Necrosis of the Head of Humerus
- What is being tested?
- Shoulder arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 1,004 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 1 Jun 2020to Jun 2037
- 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: Study population is issued from investigators' patient population.
Who may be able to join
- Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems, according to its IFU and surgical technique.
- Patient aged 18 years and above
- Patient insured with a social security system
- Has been informed and did consent to participate to the study.
Who cannot join
- Neurological pathologies compromising the shoulder stability
- Morbid obesity
- Muscular deficiencies impairing the shoulder joint
Trial locations and contacts
22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Gabriel GUEUGNON contact
22 sites in 2 countries
France21 sites, 21 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, 80054
david.emmanuel@chu-amiens.fr
- Recruiting
CHU d' Angers
Angers, 49933
LANCIGU, MD, romain.lancigu@gmail.com
- Recruiting
Hôpital Jean Minjoz
Besançon, 25030
OBERT, Pr, MD, laurentobert@yahoo.fr
- Recruiting
Clinique Aguiléra
Biarritz, 64200
LEGER, MD
- Recruiting
Hôpital privé Saint-Martin
Caen, 14000
DORDAIN, MD, fdordain@gmail.com
- Recruiting
Infirmerie Protestante
Caluire-et-Cuire, 69300
Thierry AUTHOM, MD, +33 4.72.00.71.60, thierry.authom@infirmerie-protestante.com
- Recruiting
CHMS Chambéry
Chambéry, 73011
Emmanuel BEAUDOUIN, MD, +33 4.79.96.51.44, Emmanuel.Beaudouin@ch-metropole-savoie.fr
- Recruiting
HÔPITAUX CIVILS de Colmar
Colmar, 68024
ROBIAL, MD, fdordain@gmail.com
- Recruiting
Hôpital privé Dijon Bourgogne
Dijon, 21000
GONZALVEZ, MD, mgonzalvez@orthopedie-du-parc.fr
- Recruiting
Clinique Saint Charles
La Roche-sur-Yon, 85016
HEIZMANN, MD, jheizmann.csc@sa3h.fr
- Recruiting
Clinique chirurgicale Porte Océane
Les Sables-d'Olonne, 85101
MARCHAND, MD, drjbmarchand@gmail.com
- Recruiting
Clinique Saint Charles
Lyon, 69001
Thierry AUTHOM, MD, +33 4 26 84 20 23, thauthom@gmail.com
- Recruiting
L'hôpital privé du confluent
Nantes, 44277
BARGOIN, MD, dr.bargoin@gmail.com
- Recruiting
Hopital Bichat
Paris, 75018
BOYER, Pr, MD, patrickboyer2009@gmail.com
- Recruiting
Clinique des Maussins
Paris, 75020
Geoffroy NOURISSAT, MD, +33 1 42 03 47 37, gnourissat@wanadoo.fr
- Recruiting
Pavillon de la Mutualite
Pessac, 33608
SEIVERT, v.seivert@gmail.com
- Recruiting
Clinique Saint Michel et Sainte Anne
Quimper, 29000
SONNARD, MD, a.sonnard@orange.fr
- Recruiting
Clinique Mutualiste
Saint-Etienne, 42000
BARAY, MD, ABARAY@mutualite-loire.com
- Recruiting
Polyclinique de l'Atlantique
Saint-Herblain, 44819
PAUMIER, MD, drpaumier@polyclinique-atlantique.fr
- Recruiting
C. H. St- Nazaire
Saint-Nazaire, 44606
JAMARD, MD, f.jamard@ch-saintnazaire.fr
- Recruiting
Clinique de l'Orangerie
Strasbourg, 67000
ANTONI, MD, dr.maxime.antoni@gmail.com
Monaco1 site, 1 recruiting
- Recruiting
Centre Hospitalier Princesse Grace
Monaco, 98000
Tristan LASCAR, MD, +377 97 98 97 14, tristan.lascar@chpg.mc
About this study
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS.
The included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term.
Read more
Secondary objectives are
- Revision rate at each post op visit
- Range of motion at each post op visit
- Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit
- Radiological assessment of implant positioning through geometrical parameters at each post op visit
- Incidence of complications at each post op visit
- Qualitative feedback from surgeons on the instrumentation
Read the detailed description
1004 cases are planned to be included in 11 groups of implants (range, indication and constructs).
Recruitment of patients can be retrospective or prospective, preferrably prospective.
Prospective follow-up of the patients after inclusion at 6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years , 7 years and 10 years postoperatively.
- Conditions
- Humeral Fracture, Proximal, Glenohumeral Osteoarthritis, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear, Rotator Cuff Arthropathy, Inflammatory Arthritis
- Being tested
- Shoulder arthroplasty
- Medical subject headings
- Shoulder Fractures, Rotator Cuff Injuries, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder arthroplastyProcedure or surgery
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: HUMELOCK II® TSA | Subjects treated with HUMELOCK II® Anatomic Shoulder System Receives: Procedure: Shoulder arthroplasty | |
| Group 21: cementless HUMELOCK II® RSA - trauma | Subjects treated with cementless HUMELOCK II® Reversible Shoulder System for traumatic indications Receives: Procedure: Shoulder arthroplasty | |
| Group 22: cemented long HUMELOCK II® RSA - revision | Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for revision indications Receives: Procedure: Shoulder arthroplasty | |
| Group 31: SHUMELOCK REVERSED® - degenerative | Subjects treated with HUMELOCK REVERSED® Shoulder System for degenerative indications Receives: Procedure: Shoulder arthroplasty | |
| Group 32: HUMELOCK REVERSED® - trauma | Subjects treated with HUMELOCK REVERSED® Shoulder System for traumatic indications Receives: Procedure: Shoulder arthroplasty | |
| Group 4: cementless HUMERIS® Anatomic - degenerative | Subjects treated with cementless HUMERIS® Anatomic Shoulder System for degenerative indications Receives: Procedure: Shoulder arthroplasty | |
| Group 5: cementless HUMERIS® RSA - degenerative | Subjects treated with cementless HUMERIS® Reversible Shoulder System for degenerative indications Receives: Procedure: Shoulder arthroplasty | |
| Group 6: EASYTECH® TSA - degenerative | Subjects treated with EASYTECH® Anatomic Shoulder System for degenerative indications Receives: Procedure: Shoulder arthroplasty | |
| Group 7: EASYTECH® RSA - revision | Subjects treated with EASYTECH® Reversible Shoulder System for revision indications Receives: Procedure: Shoulder arthroplasty | |
| Group 8: EASYTECH® RSA - degenerative | Subjects treated with EASYTECH® Reversed Shoulder System for degenerative indications Receives: Procedure: Shoulder arthroplasty | |
| Group 33: HUMELOCK REVERSED® - revision | Subjects treated with HUMELOCK REVERSED® Shoulder System for revision indications Receives: Procedure: Shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision rate (KM) at 10 years postoperative
Measured: at the end of the postoperative follow-up period of 10 years
Secondary outcomes (10)
Revision rate (KM) at each post-operative visits
Measured: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)
Range of Motions at each postoperative visit
Measured: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
QuickDASH score at each follow-up visit
Measured: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Constant-Murley score at each follow-up visit
Measured: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
ASES score at each postoperative visit
Measured: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
VAS pain at each postoperative visit
Measured: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
SSV score at each postoperative visit
Measured: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Radiological assessment of implant positioning at each postoperative visit
Measured: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Incidence of complications at each postoperative visit
Measured: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Qualitative feedback on the instrumentation
Measured: at surgery reporting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jun 2020
- Primary completion31 Dec 2036 (estimated)
- Study completionJun 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral Fracture, ProximalStudies 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
- 1,004 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FX Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558590
- Sponsor's protocol ID
- FX_PROTOC_CL_19-03
- Other IDs
- 2019-A01279-48
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
- ClinicalTrials.gov ID
- NCT07558590
- Acronym / sponsor ID
- FX_PROTOC_CL_19-03
- Conditions
- Humeral Fracture, Proximal, Glenohumeral Osteoarthritis, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear, Rotator Cuff Arthropathy, Inflammatory Arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,004 participants (estimated)
- Lead sponsor
- FX SolutionsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- Jun 2037 (estimated)
- First posted
- 30 Apr 2026 (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 takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS.
The included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term.
Secondary objectives are
- Revision rate at each post op visit
- Range of motion at each post op visit
- Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit
- Radiological assessment of implant positioning through geometrical parameters at each post op visit
- Incidence of complications at each post op visit
- Qualitative feedback from surgeons on the instrumentation
Detailed description
1004 cases are planned to be included in 11 groups of implants (range, indication and constructs).
Recruitment of patients can be retrospective or prospective, preferrably prospective.
Prospective follow-up of the patients after inclusion at 6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years , 7 years and 10 years postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Group 1: HUMELOCK II® TSA | – | Procedure: Shoulder arthroplastySubjects treated with HUMELOCK II® Anatomic Shoulder System |
| Group 21: cementless HUMELOCK II® RSA - trauma | – | Procedure: Shoulder arthroplastySubjects treated with cementless HUMELOCK II® Reversible Shoulder System for traumatic indications |
| Group 22: cemented long HUMELOCK II® RSA - revision | – | Procedure: Shoulder arthroplastySubjects treated with cemented long HUMELOCK II® Reversible Shoulder System for revision indications |
| Group 31: SHUMELOCK REVERSED® - degenerative | – | Procedure: Shoulder arthroplastySubjects treated with HUMELOCK REVERSED® Shoulder System for degenerative indications |
| Group 32: HUMELOCK REVERSED® - trauma | – | Procedure: Shoulder arthroplastySubjects treated with HUMELOCK REVERSED® Shoulder System for traumatic indications |
| Group 4: cementless HUMERIS® Anatomic - degenerative | – | Procedure: Shoulder arthroplastySubjects treated with cementless HUMERIS® Anatomic Shoulder System for degenerative indications |
| Group 5: cementless HUMERIS® RSA - degenerative | – | Procedure: Shoulder arthroplastySubjects treated with cementless HUMERIS® Reversible Shoulder System for degenerative indications |
| Group 6: EASYTECH® TSA - degenerative | – | Procedure: Shoulder arthroplastySubjects treated with EASYTECH® Anatomic Shoulder System for degenerative indications |
| Group 7: EASYTECH® RSA - revision | – | Procedure: Shoulder arthroplastySubjects treated with EASYTECH® Reversible Shoulder System for revision indications |
| Group 8: EASYTECH® RSA - degenerative | – | Procedure: Shoulder arthroplastySubjects treated with EASYTECH® Reversed Shoulder System for degenerative indications |
| Group 33: HUMELOCK REVERSED® - revision | – | Procedure: Shoulder arthroplastySubjects treated with HUMELOCK REVERSED® Shoulder System for revision indications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is issued from investigators' patient population.
Key inclusion criteria (4 listed)
- Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems, according to its IFU and surgical technique.
- Patient aged 18 years and above
- Patient insured with a social security system
- Has been informed and did consent to participate to the study.
Key exclusion criteria (3 listed)
- Neurological pathologies compromising the shoulder stability
- Morbid obesity
- Muscular deficiencies impairing the shoulder joint
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 |
|---|---|---|
| Shoulder arthroplastyTotal anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties. | Procedure or surgery | Group 1: HUMELOCK II® TSA, Group 21: cementless HUMELOCK II® RSA - trauma, Group 22: cemented long HUMELOCK II® RSA - revision, Group 31: SHUMELOCK REVERSED® - degenerative, Group 32: HUMELOCK REVERSED® - trauma, Group 33: HUMELOCK REVERSED® - revision, Group 4: cementless HUMERIS® Anatomic - degenerative, Group 5: cementless HUMERIS® RSA - degenerative, Group 6: EASYTECH® TSA - degenerative, Group 7: EASYTECH® RSA - revision, Group 8: EASYTECH® RSA - degenerative |
Primary outcome
Revision rate (KM) at 10 years postoperative
Time frame: at the end of the postoperative follow-up period of 10 years
10 secondary outcomes
Revision rate (KM) at each post-operative visits
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)
Range of Motions at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
QuickDASH score at each follow-up visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Constant-Murley score at each follow-up visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
ASES score at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
VAS pain at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
SSV score at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Radiological assessment of implant positioning at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Incidence of complications at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Qualitative feedback on the instrumentation
Time frame: at surgery reporting
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 30 Apr 2026.
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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.
Gabriel GUEUGNON contact
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humeral Fracture, Proximal and Glenohumeral Osteoarthritis, run by FX Solutions at 22 sites in 2 countries.
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 4 inclusion and 3 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Monaco. 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 Kathy TRIER, PhD (800-280-0775, ktrier@fxshouldersolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision rate (KM) at 10 years postoperative (time frame: at the end of the postoperative follow-up period of 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 30 Apr 2026.