NCT06078865|RecruitingFDA Device
FX Shoulder Prospective Clinical Study
FX Shoulder Post-Market Follow-Up Clinical Study
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FX Shoulder Post-Market Follow-Up Clinical Study
Sponsor study identifier
Secondary identifiers
OTHER · FX Shoulder Solutions
observational
600
1 country
4
Study Start
March 31, 2021
Actual (reported)Primary Completion
December 30, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 31, 2021
Actual (reported)September 26, 2023
Actual (reported)October 12, 2023
Actual (reported)December 30, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Adjusted Constant Score
6 weeks, 3, 6, 12, and 24 months.
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions
Contact the study team to confirm eligibility.
OrthoArizona
Gilbert, Arizona, 85297, United States
First Settlement Orthopedics
Marietta, Ohio, 45750, United States
Kathy Trier, PhD
FX Shoulder Solutions
First Submitted
September 26, 2023
First Posted
October 12, 2023
Study Start
March 31, 2021
Actual (reported)Primary Completion
December 30, 2031
EstimatedProphylactic Conjoint Tendon Lengthening During Reverse Shoulder Arthroplasty Outcomes
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
Orthopedics Rhode Island
Wakefield, Rhode Island, 02879, United States
Texas Orthopedic Specialists
Bedford, Texas, 76021, United States
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 9, 2026
Record last verified: 2026-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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