Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-29 @ 4:46 AM
Study NCT ID:
NCT05284357
Status:
UNKNOWN
Last Update Posted:
2022-08-12
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
Sponsor:
FX Solutions
Organization:
Study Overview
Official Title:
Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term Retro-Prospective, Non-Randomized, Non-Interventional Study
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: