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RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS

24. april 2026 opdateret af: FX Solutions

This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS.

The included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term.

Secondary objectives are

  • Revision rate at each post op visit
  • Range of motion at each post op visit
  • Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit
  • Radiological assessment of implant positioning through geometrical parameters at each post op visit
  • Incidence of complications at each post op visit
  • Qualitative feedback from surgeons on the instrumentation

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

1004 cases are planned to be included in 11 groups of implants (range, indication and constructs).

Recruitment of patients can be retrospective or prospective, preferrably prospective.

Prospective follow-up of the patients after inclusion at 6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years , 7 years and 10 years postoperatively.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1004

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Amiens, Frankrig, 80054
      • Angers, Frankrig, 49933
      • Besançon, Frankrig, 25030
      • Biarritz, Frankrig, 64200
        • Rekruttering
        • Clinique Aguilera
        • Kontakt:
          • LEGER, MD
      • Caen, Frankrig, 14000
        • Rekruttering
        • Hôpital privé Saint-Martin
        • Kontakt:
      • Caluire-et-Cuire, Frankrig, 69300
      • Chambéry, Frankrig, 73011
      • Colmar, Frankrig, 68024
      • Dijon, Frankrig, 21000
      • La Roche-sur-Yon, Frankrig, 85016
      • Les Sables-d'Olonne, Frankrig, 85101
      • Lyon, Frankrig, 69001
        • Rekruttering
        • Clinique Saint Charles
        • Kontakt:
      • Nantes, Frankrig, 44277
      • Paris, Frankrig, 75018
      • Paris, Frankrig, 75020
        • Rekruttering
        • Clinique des Maussins
        • Kontakt:
      • Pessac, Frankrig, 33608
      • Quimper, Frankrig, 29000
        • Rekruttering
        • Clinique Saint Michel et Sainte Anne
        • Kontakt:
      • Saint-Etienne, Frankrig, 42000
      • Saint-Herblain, Frankrig, 44819
      • Saint-Nazaire, Frankrig, 44606
      • Strasbourg, Frankrig, 67000
  • Monaco
      • Monaco, Monaco, 98000
        • Rekruttering
        • Centre Hospitalier Princesse Grace
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Study population is issued from investigators' patient population.

Beskrivelse

Inclusion Criteria:

  • Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems, according to its IFU and surgical technique.
  • Patient aged 18 years and above
  • Patient insured with a social security system
  • Has been informed and did consent to participate to the study.

Exclusion Criteria:

  • Neurological pathologies compromising the shoulder stability
  • Morbid obesity
  • Muscular deficiencies impairing the shoulder joint

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Group 1: HUMELOCK II® TSA
Subjects treated with HUMELOCK II® Anatomic Shoulder System
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 21: cementless HUMELOCK II® RSA - trauma
Subjects treated with cementless HUMELOCK II® Reversible Shoulder System for traumatic indications
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 22: cemented long HUMELOCK II® RSA - revision
Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for revision indications
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 31: SHUMELOCK REVERSED® - degenerative
Subjects treated with HUMELOCK REVERSED® Shoulder System for degenerative indications
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 32: HUMELOCK REVERSED® - trauma
Subjects treated with HUMELOCK REVERSED® Shoulder System for traumatic indications
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 4: cementless HUMERIS® Anatomic - degenerative
Subjects treated with cementless HUMERIS® Anatomic Shoulder System for degenerative indications
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 5: cementless HUMERIS® RSA - degenerative
Subjects treated with cementless HUMERIS® Reversible Shoulder System for degenerative indications
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 6: EASYTECH® TSA - degenerative
Subjects treated with EASYTECH® Anatomic Shoulder System for degenerative indications
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 7: EASYTECH® RSA - revision
Subjects treated with EASYTECH® Reversible Shoulder System for revision indications
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 8: EASYTECH® RSA - degenerative
Subjects treated with EASYTECH® Reversed Shoulder System for degenerative indications
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Group 33: HUMELOCK REVERSED® - revision
Subjects treated with HUMELOCK REVERSED® Shoulder System for revision indications
Procedure: Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Revision rate (KM) at 10 years postoperative
Tidsramme: at the end of the postoperative follow-up period of 10 years
at the end of the postoperative follow-up period of 10 years

Sekundære resultatmål

Resultatmål
Tidsramme
Revision rate (KM) at each post-operative visits
Tidsramme: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)
Range of Motions at each postoperative visit
Tidsramme: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
QuickDASH score at each follow-up visit
Tidsramme: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Constant-Murley score at each follow-up visit
Tidsramme: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
ASES score at each postoperative visit
Tidsramme: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
VAS pain at each postoperative visit
Tidsramme: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
SSV score at each postoperative visit
Tidsramme: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Radiological assessment of implant positioning at each postoperative visit
Tidsramme: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Incidence of complications at each postoperative visit
Tidsramme: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Qualitative feedback on the instrumentation
Tidsramme: at surgery reporting
at surgery reporting

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

FX Solutions

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2020

Primær færdiggørelse (Anslået)

31. december 2036

Studieafslutning (Anslået)

1. juni 2037

Datoer for studieregistrering

Først indsendt

24. april 2026

Først indsendt, der opfyldte QC-kriterier

24. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FX_PROTOC_CL_19-03
  • 2019-A01279-48 (Anden identifikator: ANSM)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner