An observational study in Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders and Fracture, Shoulder, sponsored by FX Shoulder Solutions. Recruiting at 4 sites in United States. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by FX Shoulder Solutions · Observational
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices and demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices.
To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements.
To provide data and analysis for presentations, abstracts, publications and other public release of results.
A patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (CCS):
The Registry will continue to follow patients to 10 years post-operative to track survivorship.
113 studies on the registry are indexed under Shoulder Fractures; 30 are open to participants now.
This study's planned enrollment of 600 is above the median of 97 across 60 observational studies indexed under Shoulder Fractures.
Browse Shoulder Fractures studies →FX Shoulder Solutions is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system.
Exclusion Criteria:
Patient who does not meet the inclusion criteria.
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions
Device: FX Artificial Shoulder Prosthesis
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
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.
Time frame: 2 years
Survivorship
Follow patient's post-operative to track survivorship.
Time frame: 10 years
Adjusted Constant Score
The Constant-Murley score (CMS) is a validated 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points) with the subject completing the assessment prior to the Investigator completing their part of the assessment. The higher the score, the higher the quality of the function. An Adjusted Constant score will be calculated using normalized values to account for age and gender, as based upon anatomical gender at birth.
Time frame: 6 weeks, 3, 6, 12, and 24 months.
QuickDASH
QuickDASH measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level. The higher the score, the higher the function and lower pain in the patient.
Time frame: 6 weeks, 3, 6, 12, and 24 months.
American Shoulder and Elbow Surgeon (ASES)
ASES is a validated patient-reported outcome which is composed of 10 functional questions and one pain VAS. The total score is of 100 maximum points and weighted evenly between pain and function
Time frame: 6 weeks, 3, 6, 12, and 24 months
Visual Analog Scale (VAS).
A validated measurement of pain in a patient where 0 indicates no pain and 100 indicates severe pain. The VAS is a straight horizontal line of fixed length.
Time frame: 6 weeks, 3, 6, 12, and 24 months
Range of Motion (ROM)
The patient performs active movements in all functional planes for the shoulder. Includes flexion, extension, abduction, adduction and internal and external rotation. Investigator estimates the range of movement and compares the affected with the unaffected shoulder and the normal expected range.
Time frame: 6 weeks, 3, 6, 12, and 24 months
Secondary Surgical Interventions (SSI)
SSI's are re-operations, revisions, and removals.
Time frame: 24 months and at 5 years postoperative
Serious Adverse Event
1. Led to a death. 2. Resulted in life threatening illness or injury. 3. Resulted in patient hospitalization or prolongation of existing hospitalization. 4. Resulted in patient disability or permanent damage or required intervention to prevent permanent impairment/damage. 5. Led to a congenital abnormality or birth defect.
Time frame: 24 months and at 5 years postoperative
Serious Adverse Device Effects (SADE)
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.
Time frame: 24 months and at 5 years postoperative.
Radiographic Reviews and Assessments.
Monitor implant integrity and signs of implant loosening.
Time frame: 24 months and at 5 years postoperative.
Survival
Subject disposition.
Time frame: 24 months and at 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Dec 2031, 128 months after the start.
Of 30 observational studies under Shoulder Fractures, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 109. This study's planned 128 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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