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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,004

participants targeted

Target at P75+ for all trials

Timeline

135mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach

2 countries

22 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

17 years study duration

Study Progress35%

Jun 2020Jun 2037

Study Start

First participant enrolled

June 1, 2020

Completed

5.9 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed

6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed

10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2036

Expected

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2037

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

16.6 years

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

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

Outcome Measures

Primary Outcomes (1)

Revision rate (KM) at 10 years postoperative
at the end of the postoperative follow-up period of 10 years

Secondary Outcomes (10)

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)
+5 more secondary outcomes