Recruiting OBSERVATIONAL NCT07558590

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

Sponsor: FX Solutions

Conditions 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

Interventions Shoulder arthroplasty

Updated 1 time since 2026 Last updated: Apr 24, 2026 Started: Jun 1, 2020 Primary completion: Dec 31, 2036 Completion: Jun 1, 2037

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Avascular Necrosis of the Head of Humerus and Glenohumeral Osteoarthritis and is currently actively recruiting participants. FX Solutions leads this study, which shows 1 recorded version since 2020 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

Change History

1 version recorded

Recruiting [daily]

Eligibility 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

Contact Information

Sponsor contact:

FX Solutions

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amiens, France , Angers, France , Besançon, France , Biarritz, France , Caen, France , Caluire-et-Cuire, France , Chambéry, France , Colmar, France , Dijon, France , La Roche-sur-Yon, France and 12 more locations