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

August 10, 2022 updated by: FX Solutions

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

416

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Antony, France, 92160
        • Recruiting
        • Hôpital Privé Antony
        • Contact:
        • Principal Investigator:
          • Edouard DECRETTE, MD
      • Besançon, France, 25000
        • Recruiting
        • CHU Jean Minjoz
        • Contact:
      • Bourg-en-Bresse, France, 01000
        • Recruiting
        • Centre Hospitalier Bourg En Bresse
        • Contact:
        • Principal Investigator:
          • Samuel FERRY, MD
      • Bourg-en-Bresse, France, 01000
        • Recruiting
        • Clinique Convert
        • Contact:
        • Principal Investigator:
          • Pascal CLAPPAZ, MD
      • Caluire-et-Cuire, France, 69300
      • Chalon-sur-Saône, France, 71110
        • Recruiting
        • Hôpital privé sainte Marie
        • Contact:
        • Principal Investigator:
          • Hugues DELASELLE, MD
      • Chambéry, France, 73011
      • Courbevoie, France, 92400
        • Recruiting
        • Clinique La Montagne
        • Contact:
        • Principal Investigator:
          • Marc JUVENSPAN, MD
      • Dieppe, France, 7620
        • Recruiting
        • Centre Hospitalier de Dieppe
        • Contact:
        • Principal Investigator:
          • Claire Cordier, MD
      • Lyon, France, 69001
        • Recruiting
        • Clinique Saint Charles
        • Principal Investigator:
          • Thierry AUTHOM, MD
        • Contact:
      • Muret, France, 31600
        • Recruiting
        • Clinique de l'Occitanie
        • Contact:
        • Principal Investigator:
          • Yves Bellumore, MD
      • Paris, France, 75016
        • Recruiting
        • Clinique Jouvenet
        • Contact:
        • Principal Investigator:
          • Éric LENOBLE, MD
      • Paris, France, 75020
        • Recruiting
        • Clinique des Maussins
        • Contact:
        • Principal Investigator:
          • Geoffroy NOURISSAT, MD
      • Poissy, France, 78300
        • Recruiting
        • CHI Poissy - St Germain en LayE
        • Contact:
        • Principal Investigator:
          • Nacer DEBIT, MD
      • Quincy-sous-Sénart, France, 91480
        • Recruiting
        • Hopital Privé Claude Gallien
        • Principal Investigator:
          • Éric LENOBLE, MD
        • Contact:
      • Rennes, France, 35000
        • Recruiting
        • Clinique mutualiste La Sagesse
        • Contact:
        • Principal Investigator:
          • Tewfik Benkalfate, MD
      • Saint-Malo, France, 35400
        • Recruiting
        • Centre Hospitalier de St Malo
        • Contact:
        • Principal Investigator:
          • Arthur Veil-Picard, MD
      • Trélazé, France, 49800
        • Recruiting
        • Clinique Saint Léonard
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hassan WAHAB, MD
        • Sub-Investigator:
          • Antoine GOURNAY, MD
      • Évreux, France, 27000
        • Recruiting
        • Clinique Bergouignan
        • Principal Investigator:
          • Edouard DECRETTE, MD
        • Contact:
  • Monaco
      • Monaco, Monaco, 98000
        • Recruiting
        • Centre Hospitalier Princesse Grace
        • Contact:
        • Principal Investigator:
          • Tristan LASCAR, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Studied devices are intended for adult population that are treated for arthroplasty with the studied devices. These patients are presented a pathologic shoulder pain with origin with degeneration or trauma of the articulation pathologies.

This study will include adult male and female patients from the Investigators' practice who were implanted with the FX Solution System; inclusion and exclusion criteria are defined not to introduce a too important bias of selection.

The selected patients may be representative the overall population that could treated with devices.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: Subjects implanted with HUMELOCK I & II® Anatomic Shoulder System

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

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.
Group 2: Subjects implanted with HUMELOCK II® Reversible System

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

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.
Group 3: Subjects implanted with HUMELOCK Reversed® Shoulder System

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
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)
Group 4: Subjects implanted with EASYTECH® Anatomic Shoulder System

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

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

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)

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

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)

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.
Group 7: Subjects implanted with HUMERIS® Anatomic Shoulder System

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
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.
Group 8: Subjects implanted with HUMERIS® Reversible Shoulder System

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes
Time Frame: 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
between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Articular functional measurement scores
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Revision rate
Time Frame: 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
between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Rate of complication
Time Frame: 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
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
Time Frame: 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
between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Survival rate
Time Frame: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
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
Time Frame: 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
between 6 and 10 years depending on the date of implantation of the medical device in each treatment group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FX Solutions

Investigators

  • Principal Investigator: Laurent OBERT, MD, CHU Jean Minjoz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 7, 2022

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (ACTUAL)

March 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FX_PROTOC_CL_21-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IDP for this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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