Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term

Study Overview
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Brief Summary
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This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safety and the performance at a long term and mainly the first two years of sales for each studied ranges. Eligible patients who received the FX Solutions Shoulder System and are at about 7 years post-operative were contacted by the Investigator to explain the study, the retrospective collection and the prospective follow-up visit. Investigator also explain the analysis of the post-operative outcomes of the patient. During the call of the investigator, the patient was informed about the study's goal and about the data collection. The oral agreement of the patient was checked by the investigators in CRF with its signature. Then, an information form explaining the purpose of the data collection was provided to the patient by postmail. The retrospective data were collected in a paper CRF via the medical file of patient. Post-operative follow-up for all patients is limited to a teleconsultation intended to assess the patient's current condition and clinical outcomes. Patient who are enrolled in the study shall be assigned a unique Subject Identification Number to de-identify their information.

Detailed Description
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Inclusion Criteria Adult patient (≥ 18 years old) who received one of FX Solutions Shoulder System for indication of hemi or total shoulder replacement. Patient implanted between 2011 and 2015 with a minimum follow-up of 7 years Patient has been informed of his participation in a clinical study and did not object to data collection Patient insured with a social security system Exclusion Criteria Patient who does not meet the inclusion criteria above Protected adult People deprived of their liberty Study Objectives Primary Objective: To assess functional improvement according to the Constant score evolution compared to its preoperative value Secondary Objectives, assessment of: To assess against the preoperative value: the Subjective Shoulder Value score evolution the American Shoulder and Elbow Surgeons shoulder score evolution To describe in real life The complications rate The long-term range of motion The revision rates and the prosthesis survival curve Endpoints Primary Endpoint will be the current Constant score (measured during the assessment). The functional improvement will be evaluated according to the evolution of this score compared to its preoperative value. Secondary Endpoints: Current ASES and SSV scores Current range of Motion Revision rate at a long-term follow-up. Calculation of the survival rates The incidence of complications occurring since implantation Revision rates and survival rates of prostheses Study Groups Group 1: Subjects implanted with HUMELOCK I & II® Anatomic Shoulder System 2011 to 2013 Group 2: Subjects implanted with HUMELOCK II® Reversible System 2011 to 2013 Group 3: Subjects implanted with HUMELOCK Reversed® Shoulder System - 2012 - 2013 Group 4: Subjects implanted with EASYTECH® Anatomic Shoulder System - 2013 - 2014 Group 5: Subjects implanted with EASYTECH® Reversed Shoulder System (For Primary intention only) - 2013- 2014 Group 6: additional group for Subjects who were implanted with EASYTECH® Reversible Shoulder System (Exclusively for Revision of Easytech Anatomic) - 2013 -2014, if applicable Group 7: Subjects implanted with HUMERIS® Anatomic Shoulder System 2014 to 2015 Group 8: Subjects implanted with HUMERIS® Reversible Shoulder System 2014 to 2015

Official Title
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Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term Retro-Prospective, Non-Randomized, Non-Interventional Study

Conditions
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Shoulder Disease, Shoulder Fractures, Shoulder Arthroplasty for Revision of Previous Treatment

Intervention / Treatment
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* Device: Shoulder Arthroplasty Surgery with EASYTECH® Anatomic Shoulder System
* Device: Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System
* Device: Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System
* Device: Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System
* Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversed System (Primary intention)
* Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversible System (for revision only)
* Device: Shoulder Arthroplasty Surgery with HUMERIS® Anatomic Shoulder System
* Device: Shoulder Arthroplasty Surgery with HUMERIS® Reversible Shoulder System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First of all, in order to be eligible to the study protocol, patients should have been treated primarily with one of studied device depending on surgeons' strategies' cares. In order to be eligible to participate in this study, patients must meet all of the following criteria: Adult patient (≥ 18 years old) who received one of FX Solutions Shoulder System for indication of hemi or total shoulder replacement. Patient implanted between 2011 and 2015 with a minimum follow-up of 7 years Patient has been informed of his participation in a clinical study and did not object to data collection Patient insured with a social security system Exclusion criteria for subject selection. Patient who does not meet the inclusion criteria above Protected adult People deprived of their liberty

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Subjects implanted with HUMELOCK I & II® Anatomic Shoulder System<br>The number of patients implanted was defined by comparing sales' database of FX Solutions. 97 patients were identified who could be included in this cohort in 11 investigational centers. subjects implanted in 2011 to 2013 | Device: Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System<br>* HUMELOCK II® is a new-generation of modular implant designed for the effective treatment of 3 or 4 part fractures of proximal humerus. The range of cases in which it can be used is wider than a simple reconstructive anatomical prosthesis. In fact, thanks to its anchoring plate, and if cephalic perfusion criteria are met, the modular nature of HUMELOCK II® means it is possible to retain the patient's native humeral head, even in cases of severe osteopenia. The HUMELOCK II® shoulder prosthesis allows the reconstruction of the shoulder joint as a result of a trauma (complex fracture of the proximal humerus, a common occurrence in severely injured shoulders. The HUMELOCK II® shoulder system may also be suitable for treating cases of failure of an existing shoulder prosthesis where a stem or other locking mechanism may be needed. The HUMELOCK II® shoulder prosthesis is a hemi shoulder and a total shoulder prosthesis.<br>|
| Group 2: Subjects implanted with HUMELOCK II® Reversible System<br>The number of patients implanted was defined by comparing sales' database of FX Solutions. Number of patient to be determined following patients files in 4 investigational centers. subjects implanted in 2011 to 2013 | Device: Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System<br>* HUMELOCK II® is a new-generation of modular implant designed for the effective treatment of 3 or 4 part fractures of proximal humerus. The HUMELOCK II® shoulder prosthesis allows the reconstruction of the shoulder joint as a result of a trauma (complex fracture of the proximal humerus). It is designed for use in complex shoulder reconstruction procedures in patients with stage 3 or 4 fragments in the proximal humerus - a common occurrence in severely injured shoulders. The HUMELOCK II® reversible system may also be suitable for treating cases of failure of an existing shoulder prosthesis where a stem or other locking mechanism may be needed. The HUMELOCK II reversible system is used when the rotator cuff is injured.<br>|
| Group 3: Subjects implanted with HUMELOCK Reversed® Shoulder System<br>The number of patients implanted was defined by comparing sales' database of FX Solutions. 154 patients were identified who could be included in this cohort in 5 investigational centers. subjects implanted in 2012 and 2013 | Device: Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System<br>* Humelock Reversed® is a new generation of reversed prosthesis, designed for numerous shoulder pathologies: ranging from offset arthritis to a complex cephalotuberosity fracture. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post and the position of which is guided by an intuitive adaptive instrumentation. A 145° prosthetic epiphysis allows the pillar of the scapula to be protected while maintaining optimum stability. The humeral implant is positioned naturally in the center of the epiphysis, preserving the remaining bone as much as possible. Options of locking or cementing will allow the surgeon to position the prosthetic stem at the required height, according to the patient's indication and anatomy. The surgery is called total shoulder arthroplasty. It is also indicated in a failed hemi-arthroplasty or a failed total arthroplasty. It is indicated for significant rupture of rotator cuff-tear (first surgery or revision surgery)<br>|
| Group 4: Subjects implanted with EASYTECH® Anatomic Shoulder System<br>The number of patients implanted was defined by comparing sales' database of FX Solutions. 66 patients were identified who could be included in this cohort in 5 investigational centers subjects implanted in 2013 and 2014 | Device: Shoulder Arthroplasty Surgery with EASYTECH® Anatomic Shoulder System<br>* EASYTECH Anatomical Shoulder System is indicated for use in total shoulder replacement to treat a severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis. EASYTECH system is a new generation of modular implant designed for the reconstruction of the shoulder joint for treating cases of degenerative pathology. The surgery is called total shoulder arthroplasty. EASYTECH prosthesis is a stemless system of shoulder components. It is a bone-preserving implant. The anchor base provides primary stability to pulling-out thanks to peripheral pegs in the shape of fir trees and their asymmetric orientations ensure its rotational stability<br>|
| Group 5: Subjects implanted with EASYTECH® Reversed System (Primary intention)<br>The number of patients implanted was defined by comparing sales' database of FX Solutions. 7 patients were identified who could be included in this cohort in 5 investigational centers subjects implanted in 2013 and 2014 | Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversed System (Primary intention)<br>* EASYTECH Reversed Shoulder System is indicated for primary total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear. EASYTECH system is a new generation of modular implant designed for the reconstruction of the shoulder joint for treating cases of degenerative pathology. . EASYTECH prosthesis is a stemless system of shoulder components. It is a bone-preserving implant. The anchor base provides primary stability to pulling-out thanks to peripheral pegs in the shape of fir trees and their asymmetric orientations ensure its rotational stability. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post (compatible with positioning techniques), and the position of which is guided by an intuitive adaptive instrumentation<br>|
| Group 6:Subjects implanted with EASYTECH® Reversible System (Revision of Easytech Anatomic)<br>The number of patients implanted was defined by comparing sales' database of FX Solutions. the number of subjects will depend of revised subjects primary implanted with Easytech Anatomic® along the dedicated period subjects implanted in 2013 to 2014 | Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversible System (for revision only)<br>* EASYTECH Reversible Shoulder System is indicated for revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear. EASYTECH system is a new generation of modular implant designed for the reconstruction of the shoulder joint for treating cases of degenerative pathology. . EASYTECH prosthesis is a stemless system of shoulder components. It is a bone-preserving implant. The anchor base provides primary stability to pulling-out thanks to peripheral pegs in the shape of fir trees and their asymmetric orientations ensure its rotational stability. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post (compatible with positioning techniques), and the position of which is guided by an intuitive adaptive instrumentation.<br>|
| Group 7: Subjects implanted with HUMERIS® Anatomic Shoulder System<br>The number of patients implanted was defined by comparing sales' database of FX Solutions. 11 patients were identified who could be included in this cohort in 3 investigational centers Subjects implanted in 2014 to 2015 | Device: Shoulder Arthroplasty Surgery with HUMERIS® Anatomic Shoulder System<br>* The HUMERIS Shoulder system is intended to be used in adult patients with glenohumeral joint degenerative pathologies associated or not with rotator cuff arthropathy or tears when all other non-invasive treatments have failed to reduce the pain or improve the quality of life. The HUMERIS shoulder is a system of short stem.The technical characteristics of this implant have been designed based on computer simulations, correlated to results previously published in medical journals. A 145° prosthetic epiphysis allows the pillar of the scapula to be protected while maintaining optimum stability. The humeral implant is positioned naturally in the center of the epiphysis, preserving the remaining bone as much as possible.<br>|
| Group 8: Subjects implanted with HUMERIS® Reversible Shoulder System<br>The number of patients implanted was defined by comparing sales' database of FX Solutions. 72 patients were identified who could be included in this cohort in 2 investigational centers Subjects implanted in 2014 to 2015 | Device: Shoulder Arthroplasty Surgery with HUMERIS® Reversible Shoulder System<br>* The HUMERIS Shoulder system is intended to be used in adult patients with glenohumeral joint degenerative pathologies associated or not with rotator cuff arthropathy or tears when all other non-invasive treatments have failed to reduce the pain or improve the quality of life. The HUMERIS shoulder is a system of short stem.The technical characteristics of this implant have been designed based on computer simulations, correlated to results previously published in medical journals, in order to avoid the disadvantages of traditional reverse prostheses. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post, the position of which is guided by an intuitive adaptive instrumentation.A 145° prosthetic epiphysis allows the pillar of the scapula to be protected while maintaining optimum stability.The humeral implant is positioned naturally in the center of the epiphysis, preserving the remaining bone as much as possible<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes | Functional scores measurement with Constant-Murley's Score | between 6 and 10 years depending on the date of implantation of the medical device in each treatment group | 
| Articular functional measurement scores | measurement with American Shoulder and Elbow Surgeons Shoulder Score (ASES) | between 6 and 10 years depending on the date of implantation of the medical device in each treatment group | 
| subjective evaluation by the patient of shoulder function | Measurement with subjective shoulder value (SSV) | between 6 and 10 years depending on the date of implantation of the medical device in each treatment group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion scores | Measurement of shoulder mobility (constant score) | between 6 and 10 years depending on the date of implantation of the medical device in each treatment group | 
| Revision rate | Number of patients with a change of implants out of the total number of patients reviewed in the study | between 6 and 10 years depending on the date of implantation of the medical device in each treatment group | 
| Rate of complication | All complications that had occurred will be collected in the CRF | between 6 and 10 years depending on the date of implantation of the medical device in each treatment group | 
| Last information for patient lost to follow-up | All available information about patients during his last medical follow-up | between 6 and 10 years depending on the date of implantation of the medical device in each treatment group | 
| Survival rate | Kaplan-Meier curve | between 6 and 10 years depending on the date of implantation of the medical device in each treatment group | 
| Last information for deceased patient | All available information about patients before his death | between 6 and 10 years depending on the date of implantation of the medical device in each treatment group |