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

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

• Registration Number: NCT05284357
• Lead Sponsor: FX Solutions

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-17
• Study Start: 2022-04-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-12
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 416

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (20)

Hôpital Privé Antony; 🇫🇷 Antony, France

CHU Jean MINJOZ; 🇫🇷 Besançon, France

Centre hospitalier Bourg en Bresse; 🇫🇷 Bourg-en-Bresse, France

Clinique Convert; 🇫🇷 Bourg-en-Bresse, France

Infirmerie Protestante; 🇫🇷 Caluire-et-Cuire, France

Hopital privé Sainte Marie; 🇫🇷 Chalon-sur-Saône, France

CHMS Chambéry; 🇫🇷 Chambéry, France

Clinique La Montagne; 🇫🇷 Courbevoie, France

Centre Hospitalier de Dieppe; 🇫🇷 Dieppe, France

Clinique Saint Charles; 🇫🇷 Lyon, France

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