Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
- Conditions
- Shoulder DiseaseShoulder FracturesShoulder Arthroplasty for Revision of Previous Treatment
- Interventions
- Device: Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder SystemDevice: Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible SystemDevice: Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder SystemDevice: Shoulder Arthroplasty Surgery with EASYTECH® Reversible System (for revision only)Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversed System (Primary intention)Device: Shoulder Arthroplasty Surgery with EASYTECH® Anatomic Shoulder SystemDevice: Shoulder Arthroplasty Surgery with HUMERIS® Anatomic Shoulder SystemDevice: Shoulder Arthroplasty Surgery with HUMERIS® Reversible Shoulder System
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 416
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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 3: Subjects implanted with HUMELOCK Reversed® Shoulder System Shoulder Arthroplasty Surgery 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 Group 2: Subjects implanted with HUMELOCK II® Reversible System Shoulder Arthroplasty Surgery 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 Group 1: Subjects implanted with HUMELOCK I & II® Anatomic Shoulder System Shoulder Arthroplasty Surgery 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 Group 6:Subjects implanted with EASYTECH® Reversible System (Revision of Easytech Anatomic) Shoulder Arthroplasty Surgery with EASYTECH® Reversible System (for revision only) 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 Group 5: Subjects implanted with EASYTECH® Reversed System (Primary intention) Shoulder Arthroplasty Surgery 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 Group 4: Subjects implanted with EASYTECH® Anatomic Shoulder System Shoulder Arthroplasty Surgery 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 Group 7: Subjects implanted with HUMERIS® Anatomic Shoulder System Shoulder Arthroplasty Surgery 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 Group 8: Subjects implanted with HUMERIS® Reversible Shoulder System Shoulder Arthroplasty Surgery 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
- Primary Outcome Measures
Name Time Method 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
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)
- 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)
Centre Hospitalier Princesse Grace
🇲🇨Monaco, Monaco
Clinique Bergouignan
🇫🇷Évreux, France
Centre Hospitalier de St Malo
🇫🇷Saint-Malo, France
Clinique Saint Léonard
🇫🇷Trélazé, France
CHU Jean MINJOZ
🇫🇷Besançon, France
Hôpital Privé Antony
🇫🇷Antony, France
Centre Hospitalier de Dieppe
🇫🇷Dieppe, France
Hopital privé Sainte Marie
🇫🇷Chalon-sur-Saône, France
CHMS Chambéry
🇫🇷Chambéry, France
Clinique Convert
🇫🇷Bourg-en-Bresse, France
Infirmerie Protestante
🇫🇷Caluire-et-Cuire, France
Centre hospitalier Bourg en Bresse
🇫🇷Bourg-en-Bresse, France
Clinique Saint Charles
🇫🇷Lyon, France
Clinique La Montagne
🇫🇷Courbevoie, France
Clinique de l'Occitanie
🇫🇷Muret, France
Clinique des Maussins
🇫🇷Paris, France
CHI Poissy - St Germain en Laye
🇫🇷Poissy, France
Clinique Jouvenet
🇫🇷Paris, France
Hopital Privé Claude Gallien
🇫🇷Quincy-sous-Sénart, France
Clinique Mutualiste la Sagesse
🇫🇷Rennes, France