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

NCT07558590 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1004

Last updated 2026-04-30

No results posted yet for this study

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

Conditions

  • Humeral Fracture, Proximal
  • Glenohumeral Osteoarthritis
  • Avascular Necrosis of the Head of Humerus
  • Rotator Cuff Tear
  • Rotator Cuff Arthropathy
  • Inflammatory Arthritis
  • Revision of a Shoulder Prosthesis

Interventions

PROCEDURE

Shoulder arthroplasty

Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.

Sponsors & Collaborators

  • FX Solutions

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2036-12-31
Completion
2037-06-30
FDA Device
Yes

Countries

  • France
  • Monaco

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07558590 on ClinicalTrials.gov