Security and reliability of CUSTOMBONE ...
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Article dans une revue scientifique: Article original
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Title :
Security and reliability of CUSTOMBONE cranioplasties: A prospective multicentric study
Author(s) :
Amelot, A. [Auteur]
Sorbonne Université [SU]
Nataloni, A. [Auteur]
François, P. [Auteur]
Centre Hospitalier Régional Universitaire de Tours [CHRU Tours]
Cook, A.-R. [Auteur]
Lejeune, J.-P. [Auteur]
Thérapies Assistées par Lasers et Immunothérapies pour l'Oncologie - U 1189 [OncoThAI]
Faculté de Médecine Vétérinaire [Liège]
Baroncini, M. [Auteur]
Lille Neurosciences & Cognition - U 1172 [LilNCog]
Hénaux, P.-L. [Auteur]
Laboratoire Traitement du Signal et de l'Image [LTSI]
Service de neurochirurgie [Rennes] = Neurosurgery [Rennes]
Toussaint, Patrick [Auteur]
CHirurgie, IMagerie et REgénération tissulaire de l’extrémité céphalique - Caractérisation morphologique et fonctionnelle - UR UPJV 7516 [CHIMERE]
Peltier, J. [Auteur]
CHirurgie, IMagerie et REgénération tissulaire de l’extrémité céphalique - Caractérisation morphologique et fonctionnelle - UR UPJV 7516 [CHIMERE]
CHU Amiens-Picardie
Buffenoir, K. [Auteur]
Biomécanique et génie biomédical [BIM]
Hamel, O. [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Laboratoire d'ingénierie osteo-articulaire et dentaire [LIOAD]
Hieu, P Dam [Auteur]
Chibbaro, S. [Auteur]
Institut Jean Le Rond d'Alembert [DALEMBERT]
Kehrli, P. [Auteur]
Agroscope
Lahlou, M.A. [Auteur]
Menei, P. [Auteur]
Micro et Nanomédecines Translationnelles [MINT]
Lonjon, M. [Auteur]
Département de Neurochirurgie [Hôpital Pasteur de Nice]
Mottolese, C. [Auteur]
Université Claude Bernard Lyon 1 [UCBL]
Peruzzi, P. [Auteur]
Mahla, K. [Auteur]
Scarvada, D. [Auteur]
Le Guerinel, C [Auteur]
CHU Rothschild [AP-HP]
Caillaud, P. [Auteur]
Nuti, C. [Auteur]
Pommier, B. [Auteur]
Laboratoire d'Application de la Chimie à l'Environnement [LACE]
Faillot, T. [Auteur]
Service de neurochirurgie [CHU Clichy]
Iakovlev, G. [Auteur]
Service de neurochirurgie [CHU Clichy]
Goutagny, Stéphane [Auteur]
Service de neurochirurgie [CHU Clichy]
Lonjon, N. [Auteur]
Université de Montpellier [UM]
Mécanismes moléculaires dans les démences neurodégénératives [MMDN]
Centre Hospitalier Régional Universitaire [Montpellier] [CHRU Montpellier]
Cornu, P. [Auteur]
Bousquet, P. [Auteur]
Sabatier, P. [Auteur]
Debono, B. [Auteur]
Lescure, J.-P. [Auteur]
Vicaut, E. [Auteur]
Hôpital Lariboisière-Fernand-Widal [APHP]
Froelich, S. [Auteur]
Hôpital Lariboisière
Hieu, P. Dam [Auteur]
Le Guerinel, C. [Auteur]
Sorbonne Université [SU]
Nataloni, A. [Auteur]
François, P. [Auteur]
Centre Hospitalier Régional Universitaire de Tours [CHRU Tours]
Cook, A.-R. [Auteur]
Lejeune, J.-P. [Auteur]
Thérapies Assistées par Lasers et Immunothérapies pour l'Oncologie - U 1189 [OncoThAI]
Faculté de Médecine Vétérinaire [Liège]
Baroncini, M. [Auteur]
Lille Neurosciences & Cognition - U 1172 [LilNCog]
Hénaux, P.-L. [Auteur]
Laboratoire Traitement du Signal et de l'Image [LTSI]
Service de neurochirurgie [Rennes] = Neurosurgery [Rennes]
Toussaint, Patrick [Auteur]
CHirurgie, IMagerie et REgénération tissulaire de l’extrémité céphalique - Caractérisation morphologique et fonctionnelle - UR UPJV 7516 [CHIMERE]
Peltier, J. [Auteur]
CHirurgie, IMagerie et REgénération tissulaire de l’extrémité céphalique - Caractérisation morphologique et fonctionnelle - UR UPJV 7516 [CHIMERE]
CHU Amiens-Picardie
Buffenoir, K. [Auteur]
Biomécanique et génie biomédical [BIM]
Hamel, O. [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Laboratoire d'ingénierie osteo-articulaire et dentaire [LIOAD]
Hieu, P Dam [Auteur]
Chibbaro, S. [Auteur]
Institut Jean Le Rond d'Alembert [DALEMBERT]
Kehrli, P. [Auteur]
Agroscope
Lahlou, M.A. [Auteur]
Menei, P. [Auteur]
Micro et Nanomédecines Translationnelles [MINT]
Lonjon, M. [Auteur]
Département de Neurochirurgie [Hôpital Pasteur de Nice]
Mottolese, C. [Auteur]
Université Claude Bernard Lyon 1 [UCBL]
Peruzzi, P. [Auteur]
Mahla, K. [Auteur]
Scarvada, D. [Auteur]
Le Guerinel, C [Auteur]
CHU Rothschild [AP-HP]
Caillaud, P. [Auteur]
Nuti, C. [Auteur]
Pommier, B. [Auteur]
Laboratoire d'Application de la Chimie à l'Environnement [LACE]
Faillot, T. [Auteur]
Service de neurochirurgie [CHU Clichy]
Iakovlev, G. [Auteur]
Service de neurochirurgie [CHU Clichy]
Goutagny, Stéphane [Auteur]
Service de neurochirurgie [CHU Clichy]
Lonjon, N. [Auteur]
Université de Montpellier [UM]
Mécanismes moléculaires dans les démences neurodégénératives [MMDN]
Centre Hospitalier Régional Universitaire [Montpellier] [CHRU Montpellier]
Cornu, P. [Auteur]
Bousquet, P. [Auteur]
Sabatier, P. [Auteur]
Debono, B. [Auteur]
Lescure, J.-P. [Auteur]
Vicaut, E. [Auteur]
Hôpital Lariboisière-Fernand-Widal [APHP]
Froelich, S. [Auteur]
Hôpital Lariboisière
Hieu, P. Dam [Auteur]
Le Guerinel, C. [Auteur]
Journal title :
Neurochirurgie
Pages :
p. 301-309
Publisher :
Elsevier Masson
Publication date :
2021-07
ISSN :
0028-3770
English keyword(s) :
CUSTOMBONE
Cranioplasty
Explantation
Infection
Reconstruction
Cranioplasty
Explantation
Infection
Reconstruction
HAL domain(s) :
Sciences du Vivant [q-bio]/Médecine humaine et pathologie/Chirurgie
Sciences du Vivant [q-bio]
Sciences du Vivant [q-bio]
English abstract : [en]
BackgroundRepairing bone defects generated by craniectomy is a major therapeutic challenge in terms of bone consolidation as well as functional and cognitive recovery. Furthermore, these surgical procedures are often grafted ...
Show more >BackgroundRepairing bone defects generated by craniectomy is a major therapeutic challenge in terms of bone consolidation as well as functional and cognitive recovery. Furthermore, these surgical procedures are often grafted with complications such as infections, breaches, displacements and rejections leading to failure and thus explantation of the prosthesis.ObjectiveTo evaluate cumulative explantation and infection rates following the implantation of a tailored cranioplasty CUSTOMBONE prosthesis made of porous hydroxyapatite. One hundred and ten consecutive patients requiring cranial reconstruction for a bone defect were prospectively included in a multicenter study constituted of 21 centres between December 2012 and July 2014. Follow-up lasted 2 years.ResultsMean age of patients included in the study was 42 ± 15 years old (y.o), composed mainly by men (57.27%). Explantations of the CUSTOMBONE prosthesis were performed in 13/110 (11.8%) patients, significantly due to infections: 9/13 (69.2%) (p < 0.0001), with 2 (15.4%) implant fracture, 1 (7.7%) skin defect and 1 (7.7%) following the mobilization of the implant. Cumulative explantation rates were successively 4.6% (SD 2.0), 7.4% (SD 2.5), 9.4% (SD 2.8) and 11.8% (SD 2.9%) at 2, 6, 12 and 24 months. Infections were identified in 16/110 (14.5%): 8/16 (50%) superficial and 8/16 (50%) deep. None of the following elements, whether demographic characteristics, indications, size, location of the implant, redo surgery, co-morbidities or medical history, were statistically identified as risk factors for prosthesis explantation or infection.ConclusionOur study provides relevant clinical evidence on the performance and safety of CUSTOMBONE prosthesis in cranial procedures. Complications that are difficulty incompressible mainly occur during the first 6 months, but can appear at a later stage (> 1 year). Thus assiduous, regular and long-term surveillances are necessary.Show less >
Show more >BackgroundRepairing bone defects generated by craniectomy is a major therapeutic challenge in terms of bone consolidation as well as functional and cognitive recovery. Furthermore, these surgical procedures are often grafted with complications such as infections, breaches, displacements and rejections leading to failure and thus explantation of the prosthesis.ObjectiveTo evaluate cumulative explantation and infection rates following the implantation of a tailored cranioplasty CUSTOMBONE prosthesis made of porous hydroxyapatite. One hundred and ten consecutive patients requiring cranial reconstruction for a bone defect were prospectively included in a multicenter study constituted of 21 centres between December 2012 and July 2014. Follow-up lasted 2 years.ResultsMean age of patients included in the study was 42 ± 15 years old (y.o), composed mainly by men (57.27%). Explantations of the CUSTOMBONE prosthesis were performed in 13/110 (11.8%) patients, significantly due to infections: 9/13 (69.2%) (p < 0.0001), with 2 (15.4%) implant fracture, 1 (7.7%) skin defect and 1 (7.7%) following the mobilization of the implant. Cumulative explantation rates were successively 4.6% (SD 2.0), 7.4% (SD 2.5), 9.4% (SD 2.8) and 11.8% (SD 2.9%) at 2, 6, 12 and 24 months. Infections were identified in 16/110 (14.5%): 8/16 (50%) superficial and 8/16 (50%) deep. None of the following elements, whether demographic characteristics, indications, size, location of the implant, redo surgery, co-morbidities or medical history, were statistically identified as risk factors for prosthesis explantation or infection.ConclusionOur study provides relevant clinical evidence on the performance and safety of CUSTOMBONE prosthesis in cranial procedures. Complications that are difficulty incompressible mainly occur during the first 6 months, but can appear at a later stage (> 1 year). Thus assiduous, regular and long-term surveillances are necessary.Show less >
Language :
Anglais
Peer reviewed article :
Oui
Audience :
Internationale
Popular science :
Non
Source :
Submission date :
2025-01-22T22:04:42Z