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

FX Shoulder Solutions

Status: Enrolling

Conditions: Shoulder Fractures; Shoulder Disease; Shoulder Arthroplasty for Revision of Previous Treatment

Treatments: Device: Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System; Device: Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System; Device: Shoulder Arthroplasty Surgery with HUMERIS® Reversible Shoulder System; 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 HUMERIS® Anatomic Shoulder System; Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversible System (for revision only); Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversed System (Primary intention)

Study type: Observational

Funder types: Industry

Identifiers

NCT05284357

FX_PROTOC_CL_21-02

Details and patient eligibility

About

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.

Full description

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

Enrollment: 416 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

416 participants in 8 patient groups

Group 1: Subjects implanted with HUMELOCK I & II® Anatomic Shoulder System

Description:

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

Treatment:

Device: Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System

Group 2: Subjects implanted with HUMELOCK II® Reversible System

Description:

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

Treatment:

Device: Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System

Group 3: Subjects implanted with HUMELOCK Reversed® Shoulder System

Description:

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

Treatment:

Device: Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System

Group 4: Subjects implanted with EASYTECH® Anatomic Shoulder System

Description:

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

Treatment:

Device: Shoulder Arthroplasty Surgery with EASYTECH® Anatomic Shoulder System

Group 5: Subjects implanted with EASYTECH® Reversed System (Primary intention)

Description:

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

Treatment:

Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversed System (Primary intention)

Group 6:Subjects implanted with EASYTECH® Reversible System (Revision of Easytech Anatomic)

Description:

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

Treatment:

Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversible System (for revision only)

Group 7: Subjects implanted with HUMERIS® Anatomic Shoulder System

Description:

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

Treatment:

Device: Shoulder Arthroplasty Surgery with HUMERIS® Anatomic Shoulder System

Group 8: Subjects implanted with HUMERIS® Reversible Shoulder System

Description:

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

Treatment:

Device: Shoulder Arthroplasty Surgery with HUMERIS® Reversible Shoulder System