Humeral Fracture, ProximalNCT07663552
Retro-Prospective Postmarket Clinical Study For FX Shoulder Solutions Long Cemented HUMELOCK II®
An observational study of Humeral Fracture, Proximal and Revision of a Shoulder Prosthesis, run by FX Solutions at 4 sites in France.
Trial summary
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) 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, Revision of a Shoulder Prosthesis
- What is being tested?
- Shoulder arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 4 sitesFrance
- Study dates
- Jul 2026to 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 anatomic or total reversible shoulder replacement with Long Cemented HUMELOCK II® humeral stem for Trauma or Revision indication, 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
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gabriel GUEUGNON contact
France4 sites
CHU d' Angers
Angers, 49933
Romain LANCIGU, MD, +33 6 07 02 11 34, romain.lancigu@gmail.com
Hôpital privé Saint-Martin
Caen, 14000
Franck DORDAIN, MD, +33 2 31 06 02 56, fdordain@gmail.com
Clinique Drouot Laffitte
Paris, 75009
Jules DERANLOT, MD, +33 6 63 55 83 40, dr.deranlot@gmail.com
Hôpital Nord
Saint-Priest-en-Jarez, 42277
Giorgio GRESTA, MD, +33 6 82 79 82 89, gresta@netcourrier.com
About this study
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) 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
- Constant Score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Pain score (VAS) 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
Read the detailed description
Recruitment of patients can be retrospective or prospective, mainly retrospectively. Follow-up will be prospective from the date of study inception.
Recruitment will include all cases available at the selected investigation centers.
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.
- Being tested
- Shoulder arthroplasty
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder arthroplastyProcedure or surgery
Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Trauma Indications | Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for traumatic indications Receives: Procedure: Shoulder arthroplasty | |
| Group 2: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Revision Indications | Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for revision indications Receives: Procedure: Shoulder arthroplasty | |
| Group 3: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Trauma Indications | Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for traumatic indications Receives: Procedure: Shoulder arthroplasty | |
| Group 4: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Revision Indications | Subjects treated with cemented long HUMELOCK II® Reversible 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
Survival rate (%) at 10 years calculated by means of Kaplan-Meier method
Measured: at the end of the postoperative follow-up period of 10 years
Secondary outcomes (7)
Revision rate (KM) at each postoperative visit
Survival rate (%) at each postoperative visit calculated by means of Kaplan-Meier method
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)
Constant-Murley score at each postopererative visit
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function and the lower the pain is.
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
ASES (American Shoulder and Elbow Surgeons) score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.
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
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startJul 2026 (estimated)
- 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
- 40 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
- NCT07663552
- Sponsor's protocol ID
- FX_PROTOC_CL_25-01
- Other IDs
- 2026-A00760-51
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 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 23 Jun 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 Long Cemented HUMELOCK II®
- ClinicalTrials.gov ID
- NCT07663552
- Acronym / sponsor ID
- FX_PROTOC_CL_25-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- FX SolutionsIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- Jun 2037 (estimated)
- First posted
- 23 Jun 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 HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) 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
- Constant Score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Pain score (VAS) 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
Detailed description
Recruitment of patients can be retrospective or prospective, mainly retrospectively. Follow-up will be prospective from the date of study inception.
Recruitment will include all cases available at the selected investigation centers.
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
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Trauma Indications | – | Procedure: Shoulder arthroplastySubjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for traumatic indications |
| Group 2: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Revision Indications | – | Procedure: Shoulder arthroplastySubjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for revision indications |
| Group 3: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Trauma Indications | – | Procedure: Shoulder arthroplastySubjects treated with cemented long HUMELOCK II® Reversible Shoulder System for traumatic indications |
| Group 4: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Revision Indications | – | Procedure: Shoulder arthroplastySubjects treated with cemented long HUMELOCK II® Reversible 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 anatomic or total reversible shoulder replacement with Long Cemented HUMELOCK II® humeral stem for Trauma or Revision indication, 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 arthroplastyHemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties. | Procedure or surgery | Group 1: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Trauma Indications, Group 2: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Revision Indications, Group 3: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Trauma Indications, Group 4: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Revision Indications |
Primary outcome
Revision rate (KM) at 10 years postoperative
Time frame: at the end of the postoperative follow-up period of 10 years
Survival rate (%) at 10 years calculated by means of Kaplan-Meier method
7 secondary outcomes
Revision rate (KM) 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)
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)
Constant-Murley score at each postopererative 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)
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)
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 23 Jun 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humeral Fracture, Proximal and Revision of a Shoulder Prosthesis, run by FX Solutions at 4 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 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: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 23 Jun 2026.