RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS

RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS

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

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.

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