NCT07558590 RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
| NCT ID | NCT07558590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | FX Solutions |
| Condition | Humeral Fracture, Proximal |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,004 participants |
| Start Date | 2020-06-01 |
| Primary Completion | 2036-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,004 participants in total. It began in 2020-06-01 with a primary completion date of 2036-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Neurological pathologies compromising the shoulder stability * Morbid obesity * Muscular deficiencies impairing the shoulder joint
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07558590 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Humeral Fracture, Proximal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07558590 currently recruiting?
Yes, NCT07558590 is actively recruiting participants. Contact the research team at ktrier@fxshouldersolutions.com for enrollment information.
Where is the NCT07558590 trial being conducted?
This trial is being conducted at Amiens, France, Angers, France, Besançon, France, Biarritz, France and 11 additional locations.
Who is sponsoring the NCT07558590 clinical trial?
NCT07558590 is sponsored by FX Solutions. The trial plans to enroll 1,004 participants.