Avascular Necrosis of the Head of Humerus, Glenohumeral Osteoarthritis, Humeral Fracture, Proximal, Inflammatory Arthritis, Revision of a Shoulder Prosthesis, Rotator Cuff Arthropathy, Rotator Cuff Tear
Conditions
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
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.
Interventions
PROCEDUREShoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Sponsors
FX Solutions
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Revision rate (KM) at 10 years postoperative | at the end of the postoperative follow-up period of 10 years |
Secondary
| Measure | Time frame |
|---|---|
| Revision rate (KM) at each post-operative visits | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | at surgery reporting |
Countries
France, Monaco
Contacts
CONTACTKathy TRIER, PhD
CONTACTGabriel GUEUGNON
Outcome results
None listed