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

Shoulder Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05284357
• Other study ID #: FX_PROTOC_CL_21-02
• Status: Recruiting
• Start date: April 7, 2022
• Est. completion date: October 2022

Study information

• Verified date: August 2022
• Source: FX Solutions
• Contact: Cédric FERRY
• Phone: +33 6 09 25 13 13
• Email: clinique[@]fxsolutions.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 416
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Disease
• Shoulder Fractures

Intervention

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.
• 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.
• 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)
• 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
• 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
• 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.
• 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.
• 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

Locations

Country	Name	City	State
France	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 Bergouignan	Évreux
France	Clinique Saint Charles	Lyon
France	Clinique de l'Occitanie	Muret
France	Clinique des Maussins	Paris
France	Clinique Jouvenet	Paris
France	CHI Poissy - St Germain en Laye	Poissy
France	Hopital Privé Claude Gallien	Quincy-sous-Sénart
France	Clinique Mutualiste la Sagesse	Rennes
France	Centre Hospitalier de St Malo	Saint-Malo
France	Clinique Saint Léonard	Trélazé
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
FX Solutions

Countries where clinical trial is conducted

France,  Monaco, 

References & Publications (13)

Churchill RS. Stemless shoulder arthroplasty: current status. J Shoulder Elbow Surg. 2014 Sep;23(9):1409-14. doi: 10.1016/j.jse.2014.05.005. Epub 2014 Jul 11. Review. — View Citation

Cuff D, Pupello D, Virani N, Levy J, Frankle M. Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. J Bone Joint Surg Am. 2008 Jun;90(6):1244-51. doi: 10.2106/JBJS.G.00775. — View Citation

De Wilde LF, Audenaert EA, Berghs BM. Shoulder prostheses treating cuff tear arthropathy: a comparative biomechanical study. J Orthop Res. 2004 Nov;22(6):1222-30. — View Citation

Frankle M, Levy JC, Pupello D, Siegal S, Saleem A, Mighell M, Vasey M. The reverse shoulder prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. a minimum two-year follow-up study of sixty patients surgical technique. J Bone Joint Surg Am. 2006 Sep;88 Suppl 1 Pt 2:178-90. — View Citation

Franklin JL, Barrett WP, Jackins SE, Matsen FA 3rd. Glenoid loosening in total shoulder arthroplasty. Association with rotator cuff deficiency. J Arthroplasty. 1988;3(1):39-46. — View Citation

Hawi N, Magosch P, Tauber M, Lichtenberg S, Habermeyer P. Nine-year outcome after anatomic stemless shoulder prosthesis: clinical and radiologic results. J Shoulder Elbow Surg. 2017 Sep;26(9):1609-1615. doi: 10.1016/j.jse.2017.02.017. Epub 2017 Apr 11. — View Citation

Hawi N, Tauber M, Messina MJ, Habermeyer P, Martetschläger F. Anatomic stemless shoulder arthroplasty and related outcomes: a systematic review. BMC Musculoskelet Disord. 2016 Aug 30;17(1):376. doi: 10.1186/s12891-016-1235-0. Review. — View Citation

Jazayeri R, Kwon YW. Evolution of the reverse total shoulder prosthesis. Bull NYU Hosp Jt Dis. 2011;69(1):50-5. Review. — View Citation

Lugli T. Artificial shoulder joint by Péan (1893): the facts of an exceptional intervention and the prosthetic method. Clin Orthop Relat Res. 1978 Jun;(133):215-8. — View Citation

Neer CS 2nd, Craig EV, Fukuda H. Cuff-tear arthropathy. J Bone Joint Surg Am. 1983 Dec;65(9):1232-44. — View Citation

Neer CS 2nd, Watson KC, Stanton FJ. Recent experience in total shoulder replacement. J Bone Joint Surg Am. 1982 Mar;64(3):319-37. — View Citation

NEER CS 2nd. Articular replacement for the humeral head. J Bone Joint Surg Am. 1955 Apr;37-A(2):215-28. — View Citation

Post M, Jablon M, Miller H, Singh M. Constrained total shoulder joint replacement: a critical review. Clin Orthop Relat Res. 1979 Oct;(144):135-50. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes	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
Primary	Articular functional measurement scores	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
Primary	subjective evaluation by the patient of shoulder function	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	Range of Motion scores	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
Secondary	Revision rate	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
Secondary	Rate of complication	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
Secondary	Last information for patient lost to follow-up	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
Secondary	Survival rate	Kaplan-Meier curve	between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Secondary	Last information for deceased patient	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