Safety and performance of the Hexanium TLIF system in the treatment of skeletally mature patients with degenerative disc disease – HEXANIUM TLIF Study
Résumé de l'étude
The objective of this study is to confirm the safety and performance of the Hexanium TLIF system from SPINEVISION in patients with degenerative disc disease. This observational study will collect data on the occurrence of adverse events, as well as the evolution of pain and functional disability, over a period of two years after lumbar fusion surgery with the Hexanium TLIF cage from SPINEVISION.
(BASEC)
Intervention étudiée
The surgical technique of "transforaminal lumbar intervertebral fusion" involves the implantation of a medical device (called a cage, here the Hexanium TLIF - SPINEVISION) in place of the defective intervertebral disc, which has been previously removed (partially or entirely); this is done to stabilize one to two segments at the level of the lumbar spine.
(BASEC)
Maladie en cours d'investigation
Degenerative disc disease is a natural degradation of an intervertebral disc in the spine. This degradation is often the result of natural daily stresses and minor injuries. Degenerative disc disease is typically treated with exercises, medications (pain relievers), and physical therapy. When these standard treatments prove ineffective, lumbar fusion surgery is considered.
(BASEC)
1. Patient implanted with / scheduled for implantation with the Hexanium TLIF device: • Patient already implanted with the Hexanium TLIF (implantation date not earlier than July 2021), or • Patient scheduled for implantation with the Hexanium TLIF implant; 2. Patient aged 18 years or older; 3. Patient who has given signed consent or has not opposed the collection of their data, according to local regulations. (BASEC)
Critères d'exclusion
The contraindications are as follows: - a local infection at the surgical site; - signs of local inflammation; - fever or leukocytosis; - morbid obesity; - pregnancy; - pediatric cases or patients whose skeleton is still undergoing general growth; - cases of spondylolisthesis (vertebral slippage) where reduction to grade I is impossible; - a proven or suspected allergy or intolerance to metals; - any case where the selected components for implantation are too large or too small to achieve the desired outcome; - any patient whose tissue coverage of the surgical site is inadequate, or whose bone quality or capital is poor; - any patient for whom the use of an implant would compromise the anatomical structures or expected physiological performance; - a previous arthrodesis at the level to be treated; an arthrodesis is a surgical procedure that involves fusing two or more vertebrae together to treat a back problem; - any case that does not require a bone graft or an arthrodesis; - any presence of an anomaly compromising the normal process of bone remodeling including, but not limited to: severe osteoporosis involving the spine, bone resorption, osteopenia, primary or metastatic tumors involving the spine, active infection at the site or proven metabolic disorders compromising osteogenesis; - mental disorders; - any patient unwilling to comply with post-operative instructions. (BASEC)
Lieu de l’étude
Genève
(BASEC)
Sponsor
SPINEVISION SAS Easy Medical Device
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
RANAIVOSON Hanta
+33 1 53 33 25 25
clinical.study@clutterspinevision.comSPINEVISION SAS
(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
21.11.2023
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Safety and Performance of the Hexanium® TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (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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