FX Shoulder Prospective Clinical Study

Study Overview
=================
Brief Summary
-----------------
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.

Detailed Description
-----------------
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): Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline Confidential FX Shoulder Post-Market Follow-Up Clinical Protocol Version 1.0 04 Aug 2022 9 No continuous radiolucency or device migration/subsidence No revision surgery No serious device related adverse event The Registry will continue to follow patients to 5 years post-operative to track survivorship.

Official Title
-----------------
FX Shoulder Post-Market Follow-Up Clinical Study

Conditions
-----------------
Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Fracture, Shoulder

Intervention / Treatment
-----------------
* Device: FX Artificial Shoulder Prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects<br>Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions | Device: FX Artificial Shoulder Prosthesis<br>* Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System,Easytech Anatomical Shoulder System, PRCT II Fracture Plate, V-135<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | 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. | 6 weeks, 3, 6, 12, and 24 months | 
| Secondary Surgical Interventions (SSI) | SSI's are re-operations, revisions, and removals. | 24 months and at 5 years postoperative | 
| Serious Adverse Event | Led to a death. Resulted in life threatening illness or injury. Resulted in patient hospitalization or prolongation of existing hospitalization. Resulted in patient disability or permanent damage or required intervention to prevent permanent impairment/damage. Led to a congenital abnormality or birth defect. | 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. | 24 months and at 5 years postoperative. | 
| Radiographic Reviews and Assessments. | Monitor implant integrity and signs of implant loosening. | 24 months and at 5 years postoperative. | 
| Survival | Subject disposition. | 24 months and at 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Roartator Cuff, Osteoarthritis, Fracture