Fluoroscopic Endobutton in Clavicle Fractures and AC Dislocations (KAT)
17. juni 2026 opdateret af: BOUCHRA BENKESSOU
Prospective Study on the Interest of Using an Endobutton Under Fluoroscopic Control Alone to Treat Lateral Quarter Clavicle Fractures and Severe Acromioclavicular Dislocations
This study aims to inform clinical decision-making by thoroughly examining the outcomes of different treatment approaches for lateral quarter clavicle fractures and acromioclavicular dislocations.
By evaluating the safety and efficacy of Knotless AC TightRope® repair devices and comparing short- and long-term results with other fixation techniques, the investigators hope to contribute to the improvement of treatment protocols for these common shoulder injuries.
This research could significantly impact patients' quality of life by enabling optimal recovery and restoration of shoulder function.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
10
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Paris, Frankrig, 75116
- Rekruttering
- Clinique Du Trocadéro
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Kontakt:
- bouchra benkessou, chef de projet
- Telefonnummer: 07 64 48 60 16
- E-mail: b.benkessou@hexagone-sante-paris.fr
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Kontakt:
- Bertrand BAUER, Docteur
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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
Beskrivelse
Inclusion Criteria:
- Patients presenting with a fracture of the lateral quarter of the clavicle or a severe acromioclavicular disjunction (Rockwood stages III-V) confirmed by radiological examination
- Patients who have given their consent to participate in the observational study after being informed by the surgeon
Exclusion Criteria:
- Minor patients;
- Subjects who are legally protected adults, under guardianship or trusteeship;
- Infection;
- Pregnant or breastfeeding women.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: un seul bras
To evaluate the efficacy of endo-button in the treatment of lateral quarter clavicle fractures and severe acromioclavicular dislocations
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endobutton under fluoroscopic contro
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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maintaining acromioclavicular reduction
Tidsramme: at 6 months
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The effectiveness of the endo-button (Knotless Acromioclavicular TightRope®) in maintaining acromioclavicular reduction at 6 months will be assessed through radiological imaging.
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at 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Assessment of the number of postoperative complications
Tidsramme: at 3 weeks, 3months, 6 months and 12 months
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Description of all postoperative events
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at 3 weeks, 3months, 6 months and 12 months
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Evaluation of the procedure duration
Tidsramme: at day 1
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Evaluation of the procedure duration
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at day 1
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Evaluation of the healing rate
Tidsramme: at 6 months
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Evaluation of the healing rate
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at 6 months
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Postoperative pain assessment
Tidsramme: at 3 weeks, 3 months, 6 months ans 12 months
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Postoperative pain assessment aims to measure the intensity, location, and progression of pain experienced by the patient following surgery.
It is essential for adjusting analgesic treatments, improving patient comfort, and preventing chronic pain.
This evaluation relies on validated tools such as the Visual Analog Scale (VAS) The Visual Analog Scale (VAS) is a simple and widely used tool for measuring the intensity of pain experienced by a patient.
It consists of a horizontal line, typically 10 cm long, with one end representing "no pain" (0) and the other end representing "worst imaginable pain" (10).
The patient marks a point on the line that corresponds to their perceived pain level, and the distance from the "no pain" end to the mark is measured in centimeters to yield a score from 0 to 10.
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at 3 weeks, 3 months, 6 months ans 12 months
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Assessment of shoulder mobility recovery
Tidsramme: at 3 weeks, 3 months, 6 months and 12 months
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Assessment of shoulder mobility recovery aims to evaluate functional improvement following surgery or injury.
It relies on standardized tools such as the Constant Score, which combines pain, daily activities, range of motion, and muscle strength to provide a comprehensive and objective measure.
Additionally, the Subjective Shoulder Value (SSV) offers a simple, patient-reported metric in which the individual rates the function of the affected shoulder as a percentage compared to a normal shoulder, giving a personal perspective on recovery.
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at 3 weeks, 3 months, 6 months and 12 months
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Assessment of patients' quality of life
Tidsramme: at 3 weeks, 3 months , 6 months and 12 months
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Assessment of patients' quality of life is essential for understanding the broader impact of disease and treatment beyond clinical outcomes.
The EQ-5D scale is a standardized instrument used to measure health-related quality of life.
It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension is rated by the patient, and the results can be converted into a single index value reflecting overall health status.
The EQ-5D also includes a visual analog scale (VAS) where patients rate their perceived health from 0 (worst imaginable) to 100 (best imaginable), providing both objective and subjective insights into their well-being.
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at 3 weeks, 3 months , 6 months and 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
8. januar 2024
Primær færdiggørelse (Anslået)
1. januar 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
31. maj 2024
Først indsendt, der opfyldte QC-kriterier
17. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2023-A02204-41
Plan for individuelle deltagerdata (IPD)
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JA
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
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