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

Last updated: August 10, 2022
Sponsor: FX Solutions
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05284357
FX_PROTOC_CL_21-02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 416
Study Start date:
April 07, 2022
Estimated Completion Date:
October 31, 2022

Study 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

Connect with a study center

  • Hôpital Privé Antony

    Antony, 92160
    France

    Active - Recruiting

  • CHU Jean MINJOZ

    Besançon, 25000
    France

    Active - Recruiting

  • Centre hospitalier Bourg en Bresse

    Bourg-en-Bresse, 01000
    France

    Active - Recruiting

  • Clinique Convert

    Bourg-en-Bresse, 01000
    France

    Active - Recruiting

  • Infirmerie Protestante

    Caluire-et-Cuire, 69300
    France

    Active - Recruiting

  • Hopital privé Sainte Marie

    Chalon-sur-Saône, 71110
    France

    Active - Recruiting

  • CHMS Chambéry

    Chambéry, 73011
    France

    Active - Recruiting

  • Clinique La Montagne

    Courbevoie, 92400
    France

    Active - Recruiting

  • Centre Hospitalier de Dieppe

    Dieppe, 7620
    France

    Active - Recruiting

  • Clinique Saint Charles

    Lyon, 69001
    France

    Active - Recruiting

  • Clinique de l'Occitanie

    Muret, 31600
    France

    Active - Recruiting

  • Clinique Jouvenet

    Paris, 75016
    France

    Active - Recruiting

  • Clinique des Maussins

    Paris, 75020
    France

    Active - Recruiting

  • CHI Poissy - St Germain en Laye

    Poissy, 78300
    France

    Active - Recruiting

  • Hopital Privé Claude Gallien

    Quincy-sous-Sénart, 91480
    France

    Active - Recruiting

  • Clinique Mutualiste la Sagesse

    Rennes, 35000
    France

    Active - Recruiting

  • Centre Hospitalier de St Malo

    Saint-Malo, 35400
    France

    Active - Recruiting

  • Clinique Saint Léonard

    Trélazé, 49800
    France

    Active - Recruiting

  • Clinique Bergouignan

    Évreux, 27000
    France

    Active - Recruiting

  • Centre Hospitalier Princesse Grace

    Monaco, 98000
    Monaco

    Active - Recruiting

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