Retro-Prospective Postmarket Clinical Study For FX Shoulder Solutions Long Cemented HUMELOCK II®
Starting soon
Conditions studied: Humeral Fracture, Proximal, Revision of a Shoulder Prosthesis
In brief
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
Key facts
- Study ID
- NCT07663552
- Run by
- FX Solutions
- People needed
- 40
- Starts
- 2026-07-01
- Expected to finish
- 2037-06-01
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Neurological pathologies compromising the shoulder stability
- Morbid obesity
- Muscular deficiencies impairing the shoulder joint
Where it is running
- CHU d' Angers — Angers, France
- Hôpital privé Saint-Martin — Caen, France
- Clinique Drouot Laffitte — Paris, France
- Hôpital Nord — Saint-Priest-en-Jarez, France
Full record on ClinicalTrials.gov
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