Comparative Study of Four- and Six-Strand Flexor Tendon Repair in Zone II (FLEXSTRAND)
Comparison of Six Strand and Four Strand Techniques on the Repair of Injured Flexor Tendons of Zone II of the Hand
Flexor tendon injuries in Zone 2 of the hand remain challenging because of the need to achieve optimal tendon healing while allowing early mobilization and minimizing complications such as rupture and adhesions. Various tendon repair techniques have been described, including four-strand and six-strand core suture methods.
This study aims to compare the functional outcomes and complication rates between four-strand and six-strand flexor tendon repair techniques in patients with Zone 2 flexor tendon injuries.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Flexor tendon injuries of Zone 2 are among the most difficult hand injuries to manage because of the complex anatomy and the tendency for adhesion formation and tendon rupture. Advances in tendon repair techniques have focused on increasing repair strength to permit early active mobilization while maintaining tendon gliding.
Four-strand repair techniques have been widely used and provide acceptable tensile strength and clinical outcomes. However, six-strand repair techniques may provide greater biomechanical stability and potentially allow safer early mobilization with lower rupture rates. Despite these theoretical advantages, there remains ongoing debate regarding the superiority of one technique over the other in terms of functional recovery and complication profile.
This prospective comparative study will be conducted in patients presenting with acute Zone 2 flexor tendon injuries of the hand. Eligible patients will undergo tendon repair using either four-strand or six-strand core suture techniques according to study allocation. All patients will follow a standardized postoperative rehabilitation protocol.
Primary outcomes will include functional assessment using total active motion and tendon rupture rates.
The findings of this study may help determine the optimal repair technique for improving functional outcomes in Zone 2 flexor tendon injuries while minimizing complications.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Punjab Province
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Faisalabad, Punjab Province, Pakistan, 00000
- Allied Hospital, Faisalabad Medical University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Male or female participants.
- Age 18 to 50 years.
- Zone II flexor tendon injury of the hand.
- Presentation within one week of injury.
- Willingness to participate and provide informed consent.
- Ability to comply with the postoperative rehabilitation protocol.
Exclusion Criteria:
- Injuries that interfere with postoperative rehabilitation.
- Extensive soft tissue damage associated with the tendon injury.
- Previous tendon injury in the same digit or hand region.
- Previous surgery in the same affected area.
- Non-compliance or anticipated inability to comply with the postoperative rehabilitation protocol.
- Evidence of a psychological or personality disorder that may affect participation or outcome assessment.
- Systemic illness that may compromise wound or tendon healing (e.g., uncontrolled diabetes mellitus, connective tissue disorders, severe vascular disease).
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: Four strand repair group
Participants in this group will undergo repair of Zone 2 flexor tendon injuries using the four-strand core suture tendon repair technique followed by standardized postoperative rehabilitation.
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Repair of Zone 2 flexor tendon injuries using a four-strand core suture tendon repair technique performed under standard operative protocol followed by postoperative rehabilitation.
|
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Expérimental: Six strand repair group
Participants in this group will undergo repair of Zone 2 flexor tendon injuries using the six-strand core suture tendon repair technique followed by standardized postoperative rehabilitation.
|
Repair of Zone 2 flexor tendon injuries using a six-strand core suture tendon repair technique performed under standard operative protocol followed by postoperative rehabilitation.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Functional Outcome according to Tang Criteria
Délai: Three months after Tendon repair
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Functional outcome assessed using the Tang classification (Excellent, Good, Fair, Poor) based on total active motion of the injured finger.
The higher the Tang score, the better functional outcome.
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Three months after Tendon repair
|
Collaborateurs et enquêteurs
Parrainer
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
Autres numéros d'identification d'étude
- No.48.ERC/FMU/2025-26/106
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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