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Arthroscopic Stabilization of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss (SHIELD)

15. juli 2026 opdateret af: Clinique Générale dAnnecy

Arthroscopic Stabilization of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss: A Comparison Between Dynamic Anterior Stabilization and the Latarjet Procedure

Recurrent anterior shoulder instability is a common condition among young and active patients, with a significant impact on function and a high risk of recurrence in the absence of appropriate management. Quantifying glenoid bone loss has become a central component of the treatment strategy, with losses exceeding 20 % traditionally considered critical and requiring a coracoid transfer according to the Latarjet procedure. Recent data have, however, shown that so-called "subcritical" bone loss, ranging from 13.5 to 20%, may already be associated with unfavorable clinical outcomes, particularly in highly active patients. These patients most often present with associated humeral lesions, such as Hill-Sachs lesions, and sometimes other concomitant lesions such as Humeral Avulsion of the Glenohumeral Ligament, underscoring the need for a comprehensive therapeutic approach.

Two arthroscopic techniques are currently used for this indication. The arthroscopic Latarjet procedure restores glenoid bone stock and improves dynamic stability through the combined effect of the bone block and the sling, while offering reduced morbidity compared to the open approach. Dynamic anterior stabilization (DAS), on the other hand, involves transferring the long biceps tendon to the anterior glenoid rim to replicate the sling effect in a less invasive manner, while preserving the pectoralis minor and the thoracoacromial pedicle and reducing the risk of neurological complications.

Although both techniques have shown low recurrence rates and functional improvement in the short and medium term, no Level I randomized prospective study has directly compared their outcomes in patients with subcritical glenoid bone loss and combined lesions, as the available data are primarily derived from retrospective studies or case series.

Due to the biomechanical differences between the two techniques, the associated rehabilitation protocols also differ. Thus, this study compares not only the surgical procedures themselves, but two comprehensive therapeutic strategies that include both surgery and rehabilitation.

This project aims to determine whether, in these patients, treatment with DAS yields functional outcomes comparable to those of treatment with arthroscopic Latarjet surgery while reducing morbidity and the risk of overtreatment. The evaluation will be based on validated functional and quality-of-life scores. The primary outcome measure will be the WOSI score. The results of this study could help refine surgical indications and optimize care for a population that is predominantly young and active.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

84

Fase

  • Ikke anvendelig

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:

  • aged 18 or older
  • with symptomatic recurrent anterior shoulder instability indicating the need for surgical stabilization
  • whose glenoid bone loss must be classified as subcritical, approximately between 13.5% and 20%, according to the criteria defined in the protocol
  • with HAGL lesions
  • with bone lesions
  • capable of providing informed consent and complying with the planned 24-month follow-up

Exclusion Criteria:

  • with glenoid bone loss exceeding 20%
  • with a clear indication for another procedure not covered by the protocol (particularly if routine bone grafting is required and incompatible with the study)
  • with a history of bone stabilization of the affected shoulder
  • with a transfixing rotator cuff tear or a neurological condition impairing shoulder function
  • unable to guarantee adequate follow-up
  • under legal guardianship (curatorship, guardianship, or judicial protection)
  • deprived of liberty by judicial or administrative order
  • receiving psychiatric care
  • not enrolled in a social security program

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arthroscopic Treatment of Latarjet Syndrome
The arthroscopic Latarjet procedure restores the glenoid bone stock and improves dynamic stability through the combined effect of the bone block and the band, while offering reduced morbidity compared to the open approach
Eksperimentel: Treatment Using Dynamic Anterior Stabilization (DAS) via Arthroscopy
Dynamic anterior stabilization (DAS), on the other hand, involves transferring the long biceps tendon to the anterior glenoid rim in order to replicate the sling effect in a less invasive manner, while preserving the pectoralis minor and the thoracoacromial pedicle and reducing the risk of neurological complications.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
WOSI (Western Ontario Shoulder Instability Index) score. The WOSI is a validated score specific to shoulder instability that assesses the impact of the condition on quality of life and daily activities.
Tidsramme: Month 24
To compare the impact of recurrent anterior shoulder instability associated with subcritical glenoid bone loss on quality of life and activities of daily living between DAS and arthroscopic Latarjet procedure
Month 24

Samarbejdspartnere og efterforskere

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

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 (Anslået)

20. juli 2026

Primær færdiggørelse (Anslået)

1. november 2030

Studieafslutning (Anslået)

1. november 2030

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Anterior skulder ustabilitet

Kliniske forsøg med Arthroscopic Latarjet procedure

3
Abonner