SPECT/CT evaluation of early signs of intervertebral fusion after lumbar arthrodesis with a new titanium implant.
Résumé de l'étude
Lumbar arthrodesis is a surgical procedure that involves permanently fusing one or more painful vertebrae in the lumbar spine together to eliminate their movements and ensure they behave as a single, solid bone. Thus, it can be said that lumbar arthrodesis corresponds to the fusion between several adjacent vertebrae. The main objective of this study is to evaluate the fusion rate achieved using a porous titanium cage (Juliet-TI® - Spineart).
(BASEC)
Intervention étudiée
The 2 SPECT scans will be performed using an optimized radiological dose that will target exclusively the operated region. These scans will allow us to assess the stability of the lumbar region and the intervertebral fusion after surgery.
(BASEC)
Maladie en cours d'investigation
This study is aimed at adult patients who have reached skeletal maturity and require intervertebral fusion at one or two adjacent levels, located between the lumbar vertebra L2 and the sacral vertebra S1. The study is open to all patients for whom a titanium cage (Juliet-TI® - Spineart) has been considered in the preoperative phase for the treatment of the following conditions: • Symptomatic degenerative disc disease • Spondylolisthesis due to isthmic lysis • Degenerative spondylolisthesis Grade I.
(BASEC)
- Patient with mature skeletal age - Patient treated with JULIET-TI cage at 1 or 2 levels between L2 and S1 - Patient with symptomatic degenerative spinal disease, isthmic spondylolisthesis, or degenerative spondylolisthesis Grade I - Non-smokers or patients who have stopped smoking for at least 3 months (BASEC)
Critères d'exclusion
- Patient with previous lumbar surgery between L2-S1 - Patient known for spinal fractures between L2-S1 - Patient with osteoporosis and cancer - Smoker - Spondylolisthesis Grade II or higher - Patient known for metal sensitivity - Patient known for psychiatric disorders - Patient known for neuromuscular or neurovascular diseases - Pregnant patient (not planned for the next 6 months) (BASEC)
Lieu de l’étude
Genève
(BASEC)
Sponsor
Spineart SA
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dervilla Bermingham
0041225701262
dbermingham@clutterspineart.comSpineart SA
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Genève
(BASEC)
Date d'approbation du comité d'éthique
06.01.2020
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Evaluation by SPECT CT of early signs of interbody fusion following lumbar arthrodesis using a porous Titanium cage (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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