An observational study in Humeral Fracture, Proximal, Glenohumeral Osteoarthritis and Avascular Necrosis of the Head of Humerus, sponsored by FX Solutions. Recruiting at 22 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by FX Solutions · Observational
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
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.
113 studies on the registry are indexed under Shoulder Fractures; 30 are open to participants now.
This study's planned enrollment of 1,004 is above the median of 97 across 60 observational studies indexed under Shoulder Fractures.
Browse Shoulder Fractures studies →FX Solutions is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study population is issued from investigators' patient population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects treated with HUMELOCK II® Anatomic Shoulder System
Procedure: Shoulder arthroplasty
Subjects treated with cementless HUMELOCK II® Reversible Shoulder System for traumatic indications
Procedure: Shoulder arthroplasty
Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for revision indications
Procedure: Shoulder arthroplasty
Subjects treated with HUMELOCK REVERSED® Shoulder System for degenerative indications
Procedure: Shoulder arthroplasty
Subjects treated with HUMELOCK REVERSED® Shoulder System for traumatic indications
Procedure: Shoulder arthroplasty
Subjects treated with cementless HUMERIS® Anatomic Shoulder System for degenerative indications
Procedure: Shoulder arthroplasty
Subjects treated with cementless HUMERIS® Reversible Shoulder System for degenerative indications
Procedure: Shoulder arthroplasty
Subjects treated with EASYTECH® Anatomic Shoulder System for degenerative indications
Procedure: Shoulder arthroplasty
Subjects treated with EASYTECH® Reversible Shoulder System for revision indications
Procedure: Shoulder arthroplasty
Subjects treated with EASYTECH® Reversed Shoulder System for degenerative indications
Procedure: Shoulder arthroplasty
Subjects treated with HUMELOCK REVERSED® Shoulder System for revision indications
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Revision rate (KM) at 10 years postoperative
Time frame: at the end of the postoperative follow-up period of 10 years
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
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