- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02880839
Digital Navigation Enhances Cervical Pedicle Screw Placement Accuracy and Safety
Digital Navigation Enhances Cervical Pedicle Screw Placement Accuracy and Safety: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Description détaillée
History and current status of related studies
The cervical pedicle is a tiny structure adjacent to important tissues including the spinal cord and vertebral artery. Cervical pedicle screw internal fixation is the conventional treatment for cervical spine fracture, and the technique provides acceptable internal fixation; however, current manipulation methods result in high pedicle screw penetration rates, a high risk of damage to peripheral vessels and nerves, and high rates of postoperative deformity. Improved techniques and minimally invasive methods such as transcutaneous pedicle screw implantation have been designed to effectively reduce surgery-related injury while maintaining the accuracy and safety of pedicle screw implantation. Unfortunately, there is no unified standard regarding implantation of cervical pedicle screws, and many pedicle screw implantation methods are used including partial cervical lamina excision and pipeline-dredge discharge. However, both of these techniques are clinically limited because of poor maneuverability. Digital navigation is an emerging technique based on the discrete-accumulation principle. The technique integrates computer methods, numerical control, laser and new materials, and provides a new digital technique for confirming the location and orientation of cervical pedicle screws, ensuring safe surgical operation.
Features different from other related studies
Previous studies focused primarily on investigating the curative effects of pedicle screw implantation in cervical spine fracture. To the best of the investigators knowledge, there are no studies of cervical spine fracture treatment by digital navigation-assisted cervical pedicle screw placement before June 2006 in Web of Science. The investigators located two similar articles (Cervical Spondylotic Myelopathy Surgical Trial (identifier: NCT02076113) and Slotted Hole Versus Fixed Hole C-Tek (identifier: NCT00585923)) in a search of ClinicalTrials.gov up to June 2006. The outcome measures in these two studies included bony fusion Short Form 36 and the physical component score. In contrast to these two studies regarding inclusion criteria and grouping, the investigators study was designed to investigate the accuracy and safety of digital navigation-assisted cervical pedicle screw placement, hoping to provide valuable quantitative evidence for the clinical application of this technique.
Adverse events
Possible adverse events included any expected or unexpected symptoms. If severe adverse events occurred, their details including the date of occurrence and measures taken to treat the adverse events were reported to the principal investigator and the institutional review board within 24 hours.
Data collection, management, analysis and open access
Data collection: Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events were collected, processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically by data managers using a double-data entry strategy.
Data management: The locked electronic database was accessible and locked only by the project manager, and was not altered. Paper and electronic data regarding screening, informed consent, and clinical outcomes have been preserved at the Affiliated Hospital of Nantong University, China.
Data analysis: The electronic database was statistically analyzed by a professional statistician who created an outcome analysis report that was submitted to the lead researchers. An independent data monitoring committee supervised and managed the trial data, ensuring a scientific and stringent trial to yield accurate and complete data.
Data open access: Anonymized trial data was published at http://www.figshare.com.
Statistical analysis
Statistical analysis was performed by a statistician using SPSS 19.0 software (SPSS Inc.) and followed the intention-to-treat principle. Normally distributed measurement data was expressed as mean, standard deviation, and minimums and maximums. Non-normally distributed measurement data were expressed as lower quartile (q1), and median and upper quartile (q3). The Kruskal-Wallis H-test was used to compare the visual analogue scale spine scores among the three groups, and Fisher's exact test was used to compare the degree of bony fusion of the atlantoaxial joint and the incidence of adverse reactions. P < 0.05 was considered statistically significant.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Fracture of the posterior column of the cervical spine or fracture of the anterior-posterior column of the cervical spine without severe vertebral body injury
- Non-traumatic cervical lamina destabilization, including metastatic tumor and rheumatoid arthritis
- Kyphotic deformity after cervical lamina resection
- Segmental destabilization after nerve root or spinal cord decompression
- Subjected to revision after anterior cervical spine surgery
- Scheduled to undergo internal fixation by cervical pedicle screw
- Age approximately 62 years
- Either sex
- Provision of signed informed consent to participate in the trial
Exclusion Criteria:
- Cervical pedicle injury resulting from trauma or tumor
- Severe osteoporosis
- Anatomical variation of the vertebral artery
- Unable or declined to proceed with internal fixation by pedicle screws
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: Partial cervical lamina excision group
Patients in the cervical lamina partial excision group underwent partial cervical lamina excision and cervical pedicle screw internal fixation.
|
Patients with cervical fracture were assigned to undergo partial cervical lamina excision and cervical pedicle screw internal fixation.
|
Expérimental: Pipeline-dredge discharge group
Patients in the pipeline-dredge discharge group underwent pipeline-dredge discharge and cervical pedicle screw internal fixation.
|
Patients with cervical fracture were assigned to undergo pipeline-dredge discharge and cervical pedicle screw internal fixation.
|
Expérimental: Digital navigation group
Patients in the digital navigation group underwent digital navigation-assisted cervical pedicle placement.
|
Patients with cervical fracture were assigned to undergo digital navigation assisted cervical pedicle screw placement.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
the penetration degree of the cervical pedicle screws
Délai: 12 months after internal fixation
|
According to whether screws penetrated the pedicle and the degree of penetration, screw insertion was graded in three levels: grade I, pedicle screws do not penetrate the pedicular cortex; grade II, screw threads penetrate the cortex at the isthmic portion of the pedicle (no more than 1/4 length of the screw diameter); grade III, screws obviously penetrate the cortex at the isthmic portion of the pedicle (> 1/4 length of the screw diameter) with risk of peripheral nerve and vessel injury, and poor stabilization of the internal fixation.
|
12 months after internal fixation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
bony fusion rate of the atlantoaxial joint
Délai: 12 and 36 months after internal fixation
|
To evaluate fracture healing.
Bone fusion rate in the atlantoaxial joint was calculated as the percentage of patients with bony fusion of the atlantoaxial joint divided by the total patient number in each group.
|
12 and 36 months after internal fixation
|
Visual analogue scale spine score
Délai: prior to and 12 and 36 months after internal fixation
|
To evaluate cervical neck pain.
The visual analogue scale spine score ranges
|
prior to and 12 and 36 months after internal fixation
|
American Spinal Injury Association Classification
Délai: prior to and 12 and 36 months after internal fixation
|
To evaluate improvements in neurological function
|
prior to and 12 and 36 months after internal fixation
|
incidence of adverse events
Délai: 12 and 36 months after internal fixation
|
To evaluate the safety of each pedicle screw implantation method.
The incidence of adverse events was calculated as the percentage of patients developing adverse events divided by the total patient number in each group.
|
12 and 36 months after internal fixation
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Junjie Guan, Master, Affiliated Hospital Of Nantong University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NantongU_001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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
produit fabriqué et exporté des États-Unis.
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 .
Essais cliniques sur Fracture de la colonne cervicale
-
Imperial College Healthcare NHS TrustImperial College London; The Wellington Hospital, LondonComplété
-
Duke UniversityNational Cancer Institute (NCI); Jacobi Medical CenterComplété
-
Michigan State UniversityAmerican Osteopathic AssociationComplété
-
Duke UniversityUniversity of ArkansasComplété
-
New York Institute of TechnologyComplété
-
Michigan State UniversityComplété
-
NuVasiveActif, ne recrute pasTrouble discal dégénératif cervicalÉtats-Unis
-
Goethe UniversityComplétéCinématique | Fiabilité | CervicalAllemagne
-
Xin Jiang, MDInconnueBloc du plexus cervical superficielChine
-
National Cancer Institute (NCI)ComplétéPoumon | Sein | Ovaire | Cervical | RénalÉtats-Unis