Shoulder DiseaseNCT05284357
Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
An observational study of Shoulder Disease and Shoulder Fractures, run by FX Solutions at 20 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Disease, Shoulder Fractures, Shoulder Arthroplasty for Revision of Previous Treatment
- What is being tested?
- Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System, Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System and Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System
- Type of treatment
- Medical device
- How many people
- 416 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 7 Apr 2022to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient who does not meet the inclusion criteria above
- Protected adult
- People deprived of their liberty
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
France19 sites, 19 recruiting
- Recruiting
Hôpital Privé Antony
Antony, 92160
Edouard DECRETTE, MD, +33 1 81 80 22 51, decrette.edouard@gmail.com
Edouard DECRETTE, MD
- Recruiting
CHU Jean MINJOZ
Besançon, 25000
Laurent OBERT, MD, +33 3 81 66 82 85, lobert@chu-besancon.fr
Laurent OBERT, MD
- Recruiting
Centre hospitalier Bourg en Bresse
Bourg-en-Bresse, 01000
Samuel FERRY, MD, +33 4 74 45 46 47, sferry@ch-bourg01.fr
Samuel FERRY, MD
- Recruiting
Clinique Convert
Bourg-en-Bresse, 01000
Pascal CLAPPAZ, MD, +33 4 74 45 64 03, clappaz@ymail.com
Pascal CLAPPAZ, MD
- Recruiting
Infirmerie Protestante
Caluire-et-Cuire, 69300
Thierry AUTHOM, MD, +33 4.72.00.71.60, thierry.authom@infirmerie-protestante.com
Thierry AUTHOM, MD
- Recruiting
Hopital privé Sainte Marie
Chalon-sur-Saône, 71110
Hugues DELASELLE, MD, +33 3.85.97.81.91, h.delaselle@ramsaygds.fr
Hugues DELASELLE, MD
- Recruiting
CHMS Chambéry
Chambéry, 73011
Emmanuel BEAUDOUIN, MD, +33 4.79.96.51.44, Emmanuel.Beaudouin@ch-metropole-savoie.fr
Emmanuel BEAUDOUIN, MD
- Recruiting
Clinique La Montagne
Courbevoie, 92400
Marc JUVENSPAN, MD, +33 1 86 86 56 56, m.juvenspan@gmail.com
Marc JUVENSPAN, MD
- Recruiting
Centre Hospitalier de Dieppe
Dieppe, 7620
Claire Cordier, MD, +33 2 32 14 76 76, ccfuzeau@gmail.com
Claire Cordier, MD
- Recruiting
Clinique Bergouignan
Évreux, 27000
Edouard DECRETTE, MD, +33 2 32 60 00 59, cabinet.edouarddecrette@gmail.com
Edouard DECRETTE, MD
- Recruiting
Clinique Saint Charles
Lyon, 69001
Thierry AUTHOM, MD, +33 4 26 84 20 23, thauthom@gmail.com
Thierry AUTHOM, MD
- Recruiting
Clinique de l'Occitanie
Muret, 31600
Yves Bellumore, MD, +33 5 61 51 89 09, Bellumore.y@orange.fr
Yves Bellumore, MD
- Recruiting
Clinique Jouvenet
Paris, 75016
Éric LENOBLE, MD, +33 1.42.15.42.10, e.lenoble@ramsaygds.mssante.fr
Eric LENOBLE, MD
- Recruiting
Clinique des Maussins
Paris, 75020
Geoffroy NOURISSAT, MD, +33 1 42 03 47 37, gnourissat@wanadoo.fr
Geoffroy NOURISSAT, MD
- Recruiting
CHI Poissy - St Germain en Laye
Poissy, 78300
Nacer DEBIT, MD, +33 1.39.27.51.72, nacer.debit@ght-yvelinesnord.fr
Nacer DEBIT, MD
- Recruiting
Hopital Privé Claude Gallien
Quincy-sous-Sénart, 91480
Éric LENOBLE, MD, +33 1 69 39 91 46, eric.lenoble@wanadoo.fr
Éric LENOBLE, MD
- Recruiting
Clinique Mutualiste la Sagesse
Rennes, 35000
Tewfik Benkalfate, MD, +33 2 99 85 75 75, tewfik.benkalfate@hospigrandouest.fr
Tewfik Benkalfate, MD
- Recruiting
Centre Hospitalier de St Malo
St-Malo, 35400
Arthur Veil-Picard, MD, +33 2 99 21 21 21, arthur.veilpicard@gmail.com
Arthur Veil-Picard, MD
- Recruiting
Clinique Saint Léonard
Trélazé, 49800
Hassan WAHAB, MD, +33 2 41 41 73 60, hassan.wahab@villagesante.fr
Antoine GOURNAY, MD, +33 2.41.41.73.49, antoine.gournay@villagesante.fr
Monaco1 site, 1 recruiting
- Recruiting
Centre Hospitalier Princesse Grace
Monaco, 98000
Tristan LASCAR, MD, +377 97 98 97 14, tristan.lascar@chpg.mc
Tristan LASCAR, MD
About this study
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
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.
Read more
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.
Read the 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
- Conditions
- Shoulder Disease, Shoulder Fractures, Shoulder Arthroplasty for Revision of Previous Treatment
- Being tested
- Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System, Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System, Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System, Shoulder Arthroplasty Surgery with EASYTECH® Anatomic Shoulder System, Shoulder Arthroplasty Surgery with EASYTECH® Reversed System (Primary intention)
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder SystemDevice
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 SystemDevice
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 SystemDevice
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 SystemDevice
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)Device
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)Device
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 SystemDevice
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 SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System | |
| 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 Receives: Device: Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System | |
| 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 Receives: Device: Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System | |
| 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 Receives: Device: Shoulder Arthroplasty Surgery with EASYTECH® Anatomic Shoulder System | |
| 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 Receives: Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversed System (Primary intention) | |
| 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 Receives: Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversible System (for revision only) | |
| 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 Receives: Device: Shoulder Arthroplasty Surgery with HUMERIS® Anatomic Shoulder System | |
| 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 Receives: Device: Shoulder Arthroplasty Surgery with HUMERIS® Reversible Shoulder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes
Functional scores measurement with Constant-Murley's Score
Measured: 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)
Measured: 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)
Measured: 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
Measurement of shoulder mobility (constant score)
Measured: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Revision rate
Number of patients with a change of implants out of the total number of patients reviewed in the study
Measured: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Rate of complication
All complications that had occurred will be collected in the CRF
Measured: 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
All available information about patients during his last medical follow-up
Measured: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Survival rate
Kaplan-Meier curve
Measured: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Last information for deceased patient
All available information about patients before his death
Measured: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start7 Apr 2022
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Shoulder DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FX Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurent OBERT, MD, Principal investigator, CHU Jean MINJOZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284357
- Sponsor's protocol ID
- FX_PROTOC_CL_21-02
- Status last verified
- Aug 2022
- First submitted
- 23 Feb 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IDP for this study
Publications
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.
PubMed 25027481Cuff 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.
PubMed 18519317De 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.
PubMed 15475201Frankle 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.
PubMed 16951091Franklin 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.
PubMed 3361319Hawi 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.
PubMed 28410956Hawi 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.
PubMed 27577859Jazayeri R, Kwon YW. Evolution of the reverse total shoulder prosthesis. Bull NYU Hosp Jt Dis. 2011;69(1):50-5.
PubMed 21332439Lugli 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.
PubMed 357063NEER CS 2nd. Articular replacement for the humeral head. J Bone Joint Surg Am. 1955 Apr;37-A(2):215-28. No abstract available.
PubMed 14367414Neer CS 2nd, Craig EV, Fukuda H. Cuff-tear arthropathy. J Bone Joint Surg Am. 1983 Dec;65(9):1232-44.
PubMed 6654936Neer 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.
PubMed 7061549Post M, Jablon M, Miller H, Singh M. Constrained total shoulder joint replacement: a critical review. Clin Orthop Relat Res. 1979 Oct;(144):135-50.
PubMed 535215
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05284357
- Acronym / sponsor ID
- FX_PROTOC_CL_21-02
- Conditions
- Shoulder Disease, Shoulder Fractures, Shoulder Arthroplasty for Revision of Previous Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- FX SolutionsIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1: Subjects implanted with HUMELOCK I & II® Anatomic Shoulder System | – | Device: Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder SystemThe 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 | – | Device: Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible SystemThe 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 | – | Device: Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder SystemThe 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 | – | Device: Shoulder Arthroplasty Surgery with EASYTECH® Anatomic Shoulder SystemThe 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) | – | Device: 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 6:Subjects implanted with EASYTECH® Reversible System (Revision of Easytech Anatomic) | – | Device: 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 7: Subjects implanted with HUMERIS® Anatomic Shoulder System | – | Device: Shoulder Arthroplasty Surgery with HUMERIS® Anatomic Shoulder SystemThe 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 | – | Device: Shoulder Arthroplasty Surgery with HUMERIS® Reversible Shoulder SystemThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Patient who does not meet the inclusion criteria above
- Protected adult
- People deprived of their liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder SystemHUMELOCK 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. | Device | Group 1: Subjects implanted with HUMELOCK I & II® Anatomic Shoulder System |
| Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible SystemHUMELOCK 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. | Device | Group 2: Subjects implanted with HUMELOCK II® Reversible System |
| Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder SystemHumelock 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) | Device | Group 3: Subjects implanted with HUMELOCK Reversed® Shoulder System |
| Shoulder Arthroplasty Surgery with EASYTECH® Anatomic Shoulder SystemEASYTECH 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 | Device | Group 4: Subjects implanted with EASYTECH® Anatomic Shoulder System |
| 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 | Device | Group 5: Subjects implanted with EASYTECH® Reversed System (Primary intention) |
| 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. | Device | Group 6:Subjects implanted with EASYTECH® Reversible System (Revision of Easytech Anatomic) |
| Shoulder Arthroplasty Surgery with HUMERIS® Anatomic Shoulder SystemThe 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. | Device | Group 7: Subjects implanted with HUMERIS® Anatomic Shoulder System |
| Shoulder Arthroplasty Surgery with HUMERIS® Reversible Shoulder SystemThe 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 | Device | Group 8: Subjects implanted with HUMERIS® Reversible Shoulder System |
Primary outcome
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
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)
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)
6 secondary outcomes
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
Revision rate
Time frame: 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
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
Survival rate
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Background: PubMed 25027481Churchill 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.
- Background: PubMed 18519317Cuff 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.
- Background: PubMed 15475201De 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.
- Background: PubMed 16951091Frankle 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.
- Background: PubMed 3361319Franklin 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.
- Background: PubMed 28410956Hawi 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.
- Background: PubMed 27577859Hawi 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.
- Background: PubMed 21332439Jazayeri R, Kwon YW. Evolution of the reverse total shoulder prosthesis. Bull NYU Hosp Jt Dis. 2011;69(1):50-5.
- Background: PubMed 357063Lugli 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.
- Background: PubMed 14367414NEER CS 2nd. Articular replacement for the humeral head. J Bone Joint Surg Am. 1955 Apr;37-A(2):215-28. No abstract available.
- Background: PubMed 6654936Neer CS 2nd, Craig EV, Fukuda H. Cuff-tear arthropathy. J Bone Joint Surg Am. 1983 Dec;65(9):1232-44.
- Background: PubMed 7061549Neer 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.
- Individual participant dataSharing planned: No. No plan to share IDP for this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent OBERT, MD principal investigator
CHU Jean MINJOZ
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Disease and Shoulder Fractures, run by FX Solutions at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cédric FERRY (+33 6 09 25 13 13, clinique@fxsolutions.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes (time frame: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05284357, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.