FX Shoulder Prospective Clinical Study
FX Shoulder Post-Market Follow-Up Clinical Study
2 other identifiers
observational
600
1 country
4
Brief Summary
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Longer than P75 for all trials
4 active sites
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
Study Start
First participant enrolled
March 31, 2021
CompletedFirst Submitted
Initial submission to the registry
September 26, 2023
CompletedFirst Posted
Study publicly available on registry
October 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2031
February 9, 2026
February 1, 2026
10.8 years
September 26, 2023
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS):
Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline. No continuous radiolucency or device migration/subsidence No revision surgery No serious device related adverse event.
2 years
Survivorship
Follow patient's post-operative to track survivorship.
10 years
Secondary Outcomes (10)
Adjusted Constant Score
6 weeks, 3, 6, 12, and 24 months.
QuickDASH
6 weeks, 3, 6, 12, and 24 months.
American Shoulder and Elbow Surgeon (ASES)
6 weeks, 3, 6, 12, and 24 months
Visual Analog Scale (VAS).
6 weeks, 3, 6, 12, and 24 months
Range of Motion (ROM)
6 weeks, 3, 6, 12, and 24 months
- +5 more secondary outcomes
Study Arms (1)
Subjects
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions
Interventions
Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, FXV135 Mini Shoulder System, FXV135 Humelock Shoulder System
Eligibility Criteria
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions
You may qualify if:
- Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
OrthoArizona
Gilbert, Arizona, 85297, United States
First Settlement Orthopedics
Marietta, Ohio, 45750, United States
Orthopedics Rhode Island
Wakefield, Rhode Island, 02879, United States
Texas Orthopedic Specialists
Bedford, Texas, 76021, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kathy Trier, PhD
FX Shoulder Solutions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2023
First Posted
October 12, 2023
Study Start
March 31, 2021
Primary Completion (Estimated)
December 30, 2031
Study Completion (Estimated)
December 30, 2031
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share