- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07715162
Arthroscopic Stabilization of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss (SHIELD)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Annecy, France, 74000
- Recrutement
- Clinique Générale d'Annecy
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Contact:
- Marion Mandon, PhD
- Numéro de téléphone: +33678277672
- E-mail: drc@vivalto-sante.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Arthroscopic Treatment of Latarjet Syndrome
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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
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Expérimental: Treatment Using Dynamic Anterior Stabilization (DAS) via Arthroscopy
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.
Délai: Month 24
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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 The total WOSI score ranges from 0, representing the best possible situation, to 2,100, indicating the highest level of discomfort.
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Month 24
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2026-19-CGA
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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