Clinical trial NCT05284357: Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Disease
Shoulder Fractures
Shoulder Arthroplasty for Revision of Previous Treatment
Lead sponsor: FX Solutions
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safety and the performance at a long term and mainly the first two years of sales for each studied ranges.

Eligible patients who received the FX Solutions Shoulder System and are at about 7 years post-operative were contacted by the Investigator to explain the study, the retrospective collection and the prospective follow-up visit. Investigator also explain the analysis of the post-operative outcomes of the patient. During the call of the investigator, the patient was informed about the study's goal and about the data collection. The oral agreement of the patient was checked by the investigators in CRF with its signature. Then, an information form explaining the purpose of the data collection was provided to the patient by postmail.

The retrospective data were collected in a paper CRF via the medical file of patient.

Post-operative follow-up for all patients is limited to a teleconsultation intended to assess the patient's current condition and clinical outcomes.

Patient who are enrolled in the study shall be assigned a unique Subject Identification Number to de-identify their information.

Detailed description: Inclusion Criteria

* Adult patient (≥ 18 years old) who received one of FX Solutions Shoulder System for indication of hemi or total shoulder replacement.
* Patient implanted between 2011 and 2015 with a minimum follow-up of 7 years
* Patient has been informed of his participation in a clinical study and did not object to data collection
* Patient insured with a social security system

Exclusion Criteria

* Patient who does not meet the inclusion criteria above
* Protected adult
* People deprived of their liberty

Study Objectives

* Primary Objective: To assess functional improvement according to the Constant score evolution compared to its preoperative value
* Secondary Objectives, assessment of:

To assess against the preoperative value:

* the Subjective Shoulder Value score evolution
* the American Shoulder and Elbow Surgeons shoulder score evolution To describe in real life
* The complications rate
* The long-term range of motion
* The revision rates and the prosthesis survival curve

Endpoints

* Primary Endpoint will be the current Constant score (measured during the assessment). The functional improvement will be evaluated according to the evolution of this score compared to its preoperative value.
* Secondary Endpoints:

Current ASES and SSV scores Current range of Motion Revision rate at a long-term follow-up. Calculation of the survival rates The incidence of complications occurring since implantation Revision rates and survival rates of prostheses

Study Groups Group 1: Subjects implanted with HUMELOCK I \& II® Anatomic Shoulder System 2011 to 2013 Group 2: Subjects implanted with HUMELOCK II® Reversible System 2011 to 2013 Group 3: Subjects implanted with HUMELOCK Reversed® Shoulder System - 2012 - 2013 Group 4: Subjects implanted with EASYTECH® Anatomic Shoulder System - 2013 - 2014 Group 5: Subjects implanted with EASYTECH® Reversed Shoulder System (For Primary intention only) - 2013- 2014 Group 6: additional group for Subjects who were implanted with EASYTECH® Reversible Shoulder System (Exclusively for Revision of Easytech Anatomic) - 2013 -2014, if applicable Group 7: Subjects implanted with HUMERIS® Anatomic Shoulder System 2014 to 2015 Group 8: Subjects implanted with HUMERIS® Reversible Shoulder System 2014 to 2015

Eligibility criteria: 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

Primary outcomes:
measure: Clinical outcomes
timeFrame: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
measure: Articular functional measurement scores
timeFrame: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
measure: subjective evaluation by the patient of shoulder function
timeFrame: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Secondary outcomes:
measure: Range of Motion scores
timeFrame: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
measure: Revision rate
timeFrame: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
measure: Rate of complication
timeFrame: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
measure: Last information for patient lost to follow-up
timeFrame: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
measure: Survival rate
timeFrame: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
measure: Last information for deceased patient
timeFrame: between 6 and 10 years depending on the date of implantation of the medical device in each treatment group
Other outcomes:
Locations:
city: Antony
country: France
facility: Hôpital Privé Antony
city: Besançon
country: France
facility: CHU Jean MINJOZ
city: Bourg-en-Bresse
country: France
facility: Centre hospitalier Bourg en Bresse
city: Bourg-en-Bresse
country: France
facility: Clinique Convert
city: Caluire-et-Cuire
country: France
facility: Infirmerie Protestante
city: Chalon-sur-Saône
country: France
facility: Hopital privé Sainte Marie
city: Chambéry
country: France
facility: CHMS Chambéry
city: Courbevoie
country: France
facility: Clinique La Montagne
city: Dieppe
country: France
facility: Centre Hospitalier de Dieppe
city: Lyon
country: France
facility: Clinique Saint Charles
city: Muret
country: France
facility: Clinique de l'Occitanie
city: Paris
country: France
facility: Clinique Jouvenet
city: Paris
country: France
facility: Clinique des Maussins
city: Poissy
country: France
facility: CHI Poissy - St Germain en Laye
city: Quincy-sous-Sénart
country: France
facility: Hopital Privé Claude Gallien
city: Rennes
country: France
facility: Clinique Mutualiste la Sagesse
city: Saint-Malo
country: France
facility: Centre Hospitalier de St Malo
city: Trélazé
country: France
facility: Clinique Saint Léonard
city: Évreux
country: France
facility: Clinique Bergouignan
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
affiliation: CHU Jean MINJOZ
name: Laurent OBERT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1016/j.orthres.2004.03.010.
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. doi: 10.2106/JBJS.F.00123.
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. doi: 10.1016/s0883-5403(88)80051-2.
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.
citation: Hawi 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.
citation: Jazayeri R, Kwon YW. Evolution of the reverse total shoulder prosthesis. Bull NYU Hosp Jt Dis. 2011;69(1):50-5.
citation: Lugli 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.
citation: NEER CS 2nd. Articular replacement for the humeral head. J Bone Joint Surg Am. 1955 Apr;37-A(2):215-28. No abstract available.
citation: Neer CS 2nd, Craig EV, Fukuda H. Cuff-tear arthropathy. J Bone Joint Surg Am. 1983 Dec;65(9):1232-44.
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. No abstract available.
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.