Retro-Prospective Postmarket Clinical Study For FX Shoulder Solutions Long Cemented HUMELOCK II®
17 juni 2026 uppdaterad av: FX Solutions
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) 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
- Constant Score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Pain score (VAS) 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
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Recruitment of patients can be retrospective or prospective, mainly retrospectively. Follow-up will be prospective from the date of study inception.
Recruitment will include all cases available at the selected investigation centers.
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.
Studietyp
Observationell
Inskrivning (Beräknad)
40
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Kathy TRIER, PhD
- Telefonnummer: 800-280-0775
- E-post: ktrier@fxshouldersolutions.com
Studera Kontakt Backup
- Namn: Gabriel GUEUGNON
- Telefonnummer: +33 6 09 25 38 08
Studieorter
-
-
-
Angers, Frankrike, 49933
- CHU d' Angers
-
Kontakt:
- Romain LANCIGU, MD
- Telefonnummer: +33 6 07 02 11 34
- E-post: romain.lancigu@gmail.com
-
Caen, Frankrike, 14000
- Hôpital privé Saint-Martin
-
Kontakt:
- Franck DORDAIN, MD
- Telefonnummer: +33 2 31 06 02 56
- E-post: fdordain@gmail.com
-
Paris, Frankrike, 75009
- Clinique Drouot Laffitte
-
Kontakt:
- Jules DERANLOT, MD
- Telefonnummer: +33 6 63 55 83 40
- E-post: dr.deranlot@gmail.com
-
Saint-Priest-en-Jarez, Frankrike, 42277
- Hopital Nord
-
Kontakt:
- Giorgio GRESTA, MD
- Telefonnummer: +33 6 82 79 82 89
- E-post: gresta@netcourrier.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Study population is issued from investigators' patient population.
Beskrivning
Inclusion Criteria:
- Indication for hemi anatomic or total reversible shoulder replacement with Long Cemented HUMELOCK II® humeral stem for Trauma or Revision indication, 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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Group 1: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Trauma Indications
Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for traumatic indications
|
Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
|
|
Group 2: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Revision Indications
Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for revision indications
|
Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
|
|
Group 3: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Trauma Indications
Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for traumatic indications
|
Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
|
|
Group 4: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Revision Indications
Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for revision indications
|
Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Revision rate (KM) at 10 years postoperative
Tidsram: at the end of the postoperative follow-up period of 10 years
|
Survival rate (%) at 10 years calculated by means of Kaplan-Meier method
|
at the end of the postoperative follow-up period of 10 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Range of Motions at each postoperative visit
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
|
|
Revision rate (KM) at each postoperative visit
Tidsram: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)
|
Survival rate (%) at each postoperative visit calculated by means of Kaplan-Meier method
|
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)
|
|
Constant-Murley score at each postopererative visit
Tidsram: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters.
These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.
The higher the score, the higher the quality of the function and the lower the pain is.
|
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
Tidsram: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
ASES (American Shoulder and Elbow Surgeons) score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.
|
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
Tidsram: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
The Visual Analogue Scale (VAS) measures pain intensity.
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
|
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
31 december 2036
Avslutad studie (Beräknad)
1 juni 2037
Studieregistreringsdatum
Först inskickad
17 juni 2026
Först inskickad som uppfyllde QC-kriterierna
17 juni 2026
Första postat (Faktisk)
23 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FX_PROTOC_CL_25-01
- 2026-A00760-51 (Annan identifierare: ANSM)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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