- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07826208
Added Diagnostic Value of CT Arthrography to MR Arthrography in Wrist Internal Derangement
Added Diagnostic Value of CT Arthrography to MR Arthrography in Suspected Wrist Internal Derangement
The wrist is a complex joint made up of small bones, cartilage, and stabilizing ligaments, including the triangular fibrocartilage complex (TFCC) and intrinsic carpal ligaments. Because these structures are small and intricate, diagnosing internal joint damage (internal derangement) after trauma or chronic pain can be challenging.
Magnetic resonance arthrography (MRA), an imaging scan performed after injecting a contrast dye into the joint, is widely used because it shows soft tissues clearly. However, MRA can sometimes miss subtle bone fragments, cartilage defects, or partial ligament tears due to lower spatial resolution. Computed tomography arthrography (CTA) provides higher-detail spatial imaging and excels at identifying small bone injuries and ligament tears, though it offers less soft-tissue contrast than MRI.
The purpose of this study is to determine whether performing CT arthrography in addition to MR arthrography improves the detection and characterization of internal wrist pathologies compared with MR arthrography alone.
Participants enrolled in this study will:
- Undergo a clinical history taking and examination regarding their wrist symptoms.
- Receive an ultrasound-guided injection into the radiocarpal joint using a sterile mixture containing iodinated contrast, gadolinium contrast, saline, and a local numbing medication (xylocaine).
- Undergo a high-resolution CT scan of the wrist immediately following the injection.
- Undergo a 1.5T MR arthrography scan.
Researchers will compare the findings between the two imaging techniques to evaluate how often adding CT arthrography identifies additional lesions that were occult or inconclusive on MR arthrography.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patients aged 15 to 60 years.
- Clinically suspected ligamentous, cartilage, tendon, or occult osseous wrist injury.
- Patients scheduled for MR arthrography of the wrist.
Exclusion Criteria:
- History of previous wrist surgery.
- Acute fractures requiring emergency management.
- Active wrist infection.
- Contraindications to iodinated or gadolinium-based contrast agents.
- Regional metallic implants causing significant imaging artifacts.
- Pregnancy.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Combined CT and MR Arthrography
Participants with clinically suspected wrist internal derangement receive an ultrasound-guided intra-articular injection into the radiocarpal joint using a combined mixture of iodinated contrast, gadolinium-based contrast, sterile saline, and xylocaine.
Immediately following the injection, participants undergo high-resolution computed tomography arthrography (HRCT) of the affected wrist.
This is followed by 1.5T magnetic resonance arthrography (MRA) with pre-contrast and post-contrast T1 SPIR sequences in axial, coronal, and sagittal planes to assess wrist internal derangement.
|
Under high-resolution ultrasound guidance, an intra-articular radiocarpal injection of approximately 5 mL is administered using a sterile mixture of iodinated contrast, gadolinium-based contrast, sterile saline, and xylocaine.
Immediately following injection, high-resolution CT arthrography is performed with 0.6 mm slice thickness and multiplanar reconstruction in axial, coronal, and sagittal planes.
Participants subsequently undergo 1.5T MR arthrography using coronal T2 SPIR (pre-contrast) and axial, coronal, and sagittal T1 SPIR sequences (post-contrast) using a dedicated wrist coil to evaluate internal derangement.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Patients With Additional Wrist Pathologies Detected by Adding CT Arthrography to MR Arthrography
Délai: Baseline
|
Assessed as the proportion of participants in whom CT arthrography identifies additional internal derangement lesions (including intrinsic scapholunate and lunotriquetral ligament tears, central triangular fibrocartilage complex tears, cartilage defects, and occult osseous abnormalities) that were missed, occult, or inconclusive on MR arthrography alone.
|
Baseline
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
- CTA & MRA in Wrist Derangement
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .