- ICH GCP
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- Essai clinique NCT07757594
FARES Versus Traction-Countertraction for Acute Anterior Shoulder Dislocation
The FARES Versus Traction-Countertraction Technique for Acute Anterior Shoulder Dislocation: A Randomized Controlled Trial
Anterior shoulder dislocation is a common orthopedic emergency that requires prompt reduction to relieve pain and restore joint function. Several techniques have been described for closed reduction, but the optimal method remains uncertain. The FARES (Fast, Reliable, and Safe) technique is a relatively new reduction method that may provide faster reduction with less pain compared with the conventional traction-countertraction technique.
This randomized controlled trial aims to compare the effectiveness and safety of the FARES technique and the traction-countertraction technique for the reduction of acute anterior shoulder dislocation in adult patients.
Eligible participants will be randomly assigned to receive reduction using either the FARES technique or the traction-countertraction technique. The study will evaluate the success rate of reduction, pain experienced during the procedure, time required for reduction, and procedure-related complications.
The findings of this study may provide evidence to guide the selection of reduction techniques for patients with acute anterior shoulder dislocation in the emergency department.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Acute anterior shoulder dislocation is one of the most common orthopedic emergencies and requires timely reduction to relieve pain, restore joint alignment, and minimize complications. Various closed reduction techniques have been described, but there is still no universal consensus regarding the optimal technique in terms of effectiveness, patient comfort, and procedural efficiency.
The FARES (Fast, Reliable, and Safe) technique is a relatively recent method for closed reduction of anterior shoulder dislocation. This technique combines gentle longitudinal traction, oscillating movements, and gradual abduction of the arm, aiming to facilitate reduction while minimizing patient discomfort. The traction-countertraction technique is a commonly used conventional method that relies on opposing forces applied by the operator and an assistant.
This study is designed to compare the outcomes of these two reduction techniques in adult patients with acute anterior shoulder dislocation. The study will evaluate whether the FARES technique provides advantages over the traction-countertraction technique regarding reduction success, pain during the procedure, reduction time, and safety outcomes.
The results of this trial may contribute to improving evidence-based decision-making for the management of acute anterior shoulder dislocation in emergency care settings.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ngoc Quyen Le, MD, PhD
- Numéro de téléphone: +84903818438
- E-mail: ngocquyenbs76@ump.edu.vn
Lieux d'étude
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Ho Chi Minh City
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Ho Chi Minh City, Ho Chi Minh City, Viêt Nam, 700000
- Recrutement
- Hospital for Traumatology and Orthopaedics
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Contact:
- Ngoc Quyen Le, MD, PhD
- Numéro de téléphone: +84903818438
- E-mail: ngocquyenbs76@ump.edu.vn
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age ≥18 years.
- Conscious and cooperative patients.
- Anterior shoulder dislocation confirmed by shoulder radiographs (anteroposterior view and Y-view).
- Time from injury to reduction <24 hours.
- Simple anterior shoulder dislocation or anterior shoulder dislocation associated with greater tuberosity fracture only.
- Patient agrees to participate in the study and provides informed consent.
Exclusion Criteria:
- Other injuries of the same upper extremity.
- Neurovascular deficits before reduction.
- Polytrauma, hemodynamic instability, or medical conditions contraindicating immediate reduction.
- Previous surgery of the affected shoulder.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: FARES Technique
Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.
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Closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.
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Comparateur actif: Traction-Countertraction Technique
Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.
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Closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Successful reduction at the first attempt
Délai: During the initial reduction procedure
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Proportion of participants achieving successful reduction using the assigned technique without requiring an alternative reduction method.
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During the initial reduction procedure
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to successful reduction
Délai: During the reduction procedure
|
The time required to achieve successful reduction, measured from the beginning of the assigned reduction maneuver until restoration of shoulder joint alignment.
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During the reduction procedure
|
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Pain intensity during reduction procedure
Délai: Immediately after completion of the reduction procedure
|
Pain intensity experienced by participants during the reduction procedure, assessed using the Visual Analog Scale (VAS).
The VAS is a continuous scale ranging from 0 (no pain) to 100 mm (worst imaginable pain), where higher scores indicate worse outcome.
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Immediately after completion of the reduction procedure
|
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Number of reduction attempts
Délai: During the reduction procedure
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The number of attempts required to achieve successful shoulder reduction using the assigned technique.
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During the reduction procedure
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Procedure-related complications
Délai: During the reduction procedure and immediate post-reduction assessment
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Incidence of complications related to the reduction procedure, including neurovascular complications and other adverse events.
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During the reduction procedure and immediate post-reduction assessment
|
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Factors associated with successful reduction
Délai: From baseline assessment until completion of the reduction procedure
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Odds ratio (with 95% confidence interval) for successful reduction associated with each baseline factor, estimated using multivariable logistic regression.
Successful reduction is defined as restoration of glenohumeral joint congruity confirmed on post-reduction radiography, achieved with the allocated technique without crossover to an alternative technique or the addition of procedural sedation.
Baseline factors entered into the model are age (years), sex (male/female), body mass index (kg/m²), mechanism of injury (fall / sports-related / road traffic accident / other), time from injury to reduction attempt (hours), history of recurrent shoulder dislocation (yes/no), and associated greater tuberosity fracture on pre-reduction radiography (yes/no).
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From baseline assessment until completion of the reduction procedure
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Pain intensity after reduction
Délai: Immediately after successful reduction
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Pain intensity after completion of the reduction procedure, assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
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Immediately after successful reduction
|
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 155/2026/HĐ-ĐHYD
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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