Extension Block Pinning vs Conservative Treatment for Mallet Finger Fractures (PO-EBPT)
Pin Orthosis Extension Block Pinning Versus Conservative Treatment for Doyle Type 4B Mallet Fractures
Mallet finger fractures are injuries affecting the tip of the finger and can be treated either with splinting or surgery. However, there is no clear agreement on which treatment provides better outcomes for certain types of these fractures.
In this study, patients with mallet finger fractures were randomly assigned to receive either surgical treatment using a pin-orthosis extension-block pinning technique or conservative treatment with splint immobilization. Patients were followed at regular intervals, and outcomes such as finger movement, function, bone healing, and complications were evaluated over time.
The purpose of this study is to compare these two treatment approaches and determine which one leads to better clinical and functional outcomes.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Mallet finger fractures, particularly those involving a significant portion of the distal interphalangeal joint articular surface, present a therapeutic challenge, and there is no consensus regarding the optimal treatment strategy. Both conservative management with splinting and various surgical techniques have been described in the literature.
This randomized controlled trial was designed to compare the clinical and radiographic outcomes of the pin-orthosis extension-block pinning technique and conventional conservative treatment in patients with mallet finger fractures. Patients were randomly assigned to either surgical or conservative treatment groups and followed at regular intervals.
Clinical and functional outcomes were assessed throughout the follow-up period to evaluate the effectiveness and safety of both treatment approaches."
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Sultangazi
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Istanbul, Sultangazi, Turquie (Türkiye), 34265
- Haseki Training and Research Hospital
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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:
- Age between 18 and 65 years
- Acute mallet fracture (≤ 3 weeks from injury)
- Fracture fragment involving 20-50% of the distal interphalangeal (DIP) joint articular surface
Exclusion Criteria:
- Open fractures
- Chronic mallet fractures (> 3 weeks from injury)
- Fracture fragment involving more than 50% of the DIP joint articular surface
- Open physes
- Inability to complete 12-month follow-up
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 |
|---|---|
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Expérimental: Surgical Treatment (PO-EBPT)
Participants in this group underwent surgical treatment using the pin-orthosis extension-block pinning technique.
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The pin-orthosis extension-block pinning technique was performed under appropriate anesthesia.
A Kirschner wire was used to block extension at the distal interphalangeal joint and stabilize the fracture fragment, followed by immobilization with an orthosis.
The fixation was maintained for a defined period, and patients were followed according to the study protocol.
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Comparateur actif: Conservative Treatment (Splinting)
Participants in this group received conservative treatment with splint immobilization of the distal interphalangeal joint.
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Conservative treatment consisted of continuous splint immobilization of the distal interphalangeal joint in extension.
Patients were instructed to maintain uninterrupted splint use for the recommended duration with regular follow-up visits to monitor compliance and clinical progress.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Distal Interphalangeal Joint Extension Lag
Délai: 12 months
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Degree of extension lag at the distal interphalangeal joint measured using a goniometer.
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Distal Interphalangeal Joint Range of Motion
Délai: Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)
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Range of motion of the distal interphalangeal joint measured in degrees.
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Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)
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Functional Outcome According to Crawford Criteria
Délai: 12 months
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Functional outcome assessed using the Crawford classification system.
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12 months
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Fracture Union
Délai: Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)
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Radiographic evidence of fracture healing assessed during follow-up.
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Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)
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Complication Rate
Délai: Up to 12 months
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Incidence of treatment-related complications observed during the study period.
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Up to 12 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Kemal A Col, Doctor, Haseki Training and Research Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- 39-2022
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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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