Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
1 other identifier
observational
416
2 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Shorter than P25 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedStudy Start
First participant enrolled
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedAugust 12, 2022
August 1, 2022
6 months
February 23, 2022
August 10, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (6)
Range of Motion scores
between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Revision rate
between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Rate of complication
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
between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Survival rate
between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
- +1 more secondary outcomes
Study Arms (8)
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
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
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
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
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
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
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
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
Interventions
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.
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.
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)
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
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
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.
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.
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Protected adult
- People deprived of their liberty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FX Solutionslead
Study Sites (20)
Hôpital Privé Antony
Antony, 92160, France
CHU Jean MINJOZ
Besançon, 25000, France
Centre hospitalier Bourg en Bresse
Bourg-en-Bresse, 01000, France
Clinique Convert
Bourg-en-Bresse, 01000, France
Infirmerie Protestante
Caluire-et-Cuire, 69300, France
Hopital privé Sainte Marie
Chalon-sur-Saône, 71110, France
CHMS Chambéry
Chambéry, 73011, France
Clinique La Montagne
Courbevoie, 92400, France
Centre Hospitalier de Dieppe
Dieppe, 7620, France
Clinique Bergouignan
Évreux, 27000, France
Clinique Saint Charles
Lyon, 69001, France
Clinique de l'Occitanie
Muret, 31600, France
Clinique Jouvenet
Paris, 75016, France
Clinique des Maussins
Paris, 75020, France
CHI Poissy - St Germain en Laye
Poissy, 78300, France
Hopital Privé Claude Gallien
Quincy-sous-Sénart, 91480, France
Clinique Mutualiste la Sagesse
Rennes, 35000, France
Centre Hospitalier de St Malo
St-Malo, 35400, France
Clinique Saint Léonard
Trélazé, 49800, France
Centre Hospitalier Princesse Grace
Monaco, 98000, Monaco
Related 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.
PMID: 25027481BACKGROUNDCuff 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.
PMID: 18519317BACKGROUNDDe 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. doi: 10.1016/j.orthres.2004.03.010.
PMID: 15475201BACKGROUNDFrankle 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. doi: 10.2106/JBJS.F.00123.
PMID: 16951091BACKGROUNDFranklin 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. doi: 10.1016/s0883-5403(88)80051-2.
PMID: 3361319BACKGROUNDHawi 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.
PMID: 28410956BACKGROUNDHawi N, Tauber M, Messina MJ, Habermeyer P, Martetschlager 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.
PMID: 27577859BACKGROUNDJazayeri R, Kwon YW. Evolution of the reverse total shoulder prosthesis. Bull NYU Hosp Jt Dis. 2011;69(1):50-5.
PMID: 21332439BACKGROUNDLugli T. Artificial shoulder joint by Pean (1893): the facts of an exceptional intervention and the prosthetic method. Clin Orthop Relat Res. 1978 Jun;(133):215-8.
PMID: 357063BACKGROUNDNEER CS 2nd. Articular replacement for the humeral head. J Bone Joint Surg Am. 1955 Apr;37-A(2):215-28. No abstract available.
PMID: 14367414BACKGROUNDNeer CS 2nd, Craig EV, Fukuda H. Cuff-tear arthropathy. J Bone Joint Surg Am. 1983 Dec;65(9):1232-44.
PMID: 6654936BACKGROUNDNeer CS 2nd, Watson KC, Stanton FJ. Recent experience in total shoulder replacement. J Bone Joint Surg Am. 1982 Mar;64(3):319-37. No abstract available.
PMID: 7061549BACKGROUNDPost M, Jablon M, Miller H, Singh M. Constrained total shoulder joint replacement: a critical review. Clin Orthop Relat Res. 1979 Oct;(144):135-50.
PMID: 535215BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent OBERT, MD
CHU Jean MINJOZ
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2022
First Posted
March 17, 2022
Study Start
April 7, 2022
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
August 12, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
No plan to share IDP for this study