1. Security and reliability of CUSTOMBONE cranioplasties: A prospective multicentric study
- Author
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Amelot, A., Nataloni, A., François, P., Cook, A.-R., Lejeune, J.-P., Baroncini, M., Hénaux, P.-L., Toussaint, P., Peltier, J., Buffenoir, K., Hamel, O., Hieu, P Dam, Chibbaro, S., Kehrli, P., Lahlou, M.A., Menei, P., Lonjon, M., Mottolese, C., Peruzzi, P., Mahla, K., Scarvada, D., Le Guerinel, C, Caillaud, P., Nuti, C., Pommier, B., Faillot, T., Iakovlev, G., Goutagny, Stéphane, Lonjon, N., Cornu, P., Bousquet, P., Sabatier, P., Debono, B., Lescure, J.-P., Vicaut, E., Froelich, S., Hieu, P. Dam, Le Guerinel, C., Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Service de neurochirurgie [Rennes] = Neurosurgery [Rennes], CHU Pontchaillou [Rennes], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Amiens-Picardie, Laboratoire d'ingénierie osteo-articulaire et dentaire (LIOAD), Université de Nantes (UN)-IFR26-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier universitaire de Nantes (CHU Nantes), Institut Jean Le Rond d'Alembert (DALEMBERT), Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Agroscope, Micro et Nanomédecines Translationnelles (MINT), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Département de Neurochirurgie [Hôpital Pasteur de Nice], Hôpital Pasteur [Nice] (CHU), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Service de neurochirurgie [CHU Clichy], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Beaujon [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité)
- Subjects
Male ,medicine.medical_treatment ,MESH: Autografts ,MESH: Plastic Surgery Procedures ,Prosthesis ,0302 clinical medicine ,Prospective Studies ,CUSTOMBONE ,Stage (cooking) ,Autografts ,Explantation ,MESH: Middle Aged ,MESH: Follow-Up Studies ,Prostheses and Implants ,Middle Aged ,Cranioplasty ,MESH: Reproducibility of Results ,030220 oncology & carcinogenesis ,Bone consolidation ,MESH: Skull ,Female ,Infection ,Craniotomy ,Adult ,medicine.medical_specialty ,MESH: Prostheses and Implants ,MESH: Craniotomy ,[SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery ,MESH: Prosthesis Implantation ,Prosthesis Implantation ,03 medical and health sciences ,medicine ,Humans ,MESH: Humans ,business.industry ,Skull ,Reproducibility of Results ,MESH: Adult ,Mean age ,Plastic Surgery Procedures ,Surgical procedures ,Bone defect ,MESH: Male ,MESH: Prospective Studies ,Surgery ,Durapatite ,Multicenter study ,Neurology (clinical) ,Reconstruction ,MESH: Durapatite ,business ,MESH: Female ,030217 neurology & neurosurgery ,Follow-Up Studies - Abstract
Repairing 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.To 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.Mean 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%) (p0.0001), 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.Our 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.
- Published
- 2021
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