Multicentric Pilot, Clinical Study of a Bone Substitute Safety and Efficacy in the Multi Traumatized Nasal Septum Reconstruction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Safety
研究概览
简要总结
The aim of this project is to evaluate the safety and efficacy of the biomaterial made of HAP/TCP (BCP, Kasios®), in septoplasties of multi traumatized human nose. The use of this biomaterial will avoid the graft sampling and we expect it to be a good substitute to support the nasal pyramid while favouring the respiratory epithelium regeneration. Thus, that would confirm previous in vitro and in vivo studies.
详细描述
Five to ten percent of the post-traumatic septo-rhinoplasties require a total reconstruction of the septal skeleton. This surgery requires using autologous bone graft (iliac, costal, or parietal). However these swabs include surgical risks, have a particular morbidity non negligible and particular quality imperfections (resorption level, texture, shape, integration) requiring a complex and long lasting shaping before implantation. To avoid the using of bone graft, a large scale of products has been developed to propose a synthetic bone substitute as a support for bone reconstruction. The bone substitute, BCP, made of hydroxyl apatite (HAP) and tricalcium phosphate (TCP), is thus largely used in orthopaedics, and CE marked in numerous indications (like sinus lift). The stake is to validate that it can be used in septo-rhino-plasties. This septic zone presents characteristics which required in vitro and in vivo studies, showing that the conclusions are a good biocompatibility of BCP for human epithelial cells and in septal area of rabbits and sheep. The ultimate step to validate this concept consists in conducting a pilot clinical study on 25 patients with the indication of septoplasties to verify its safety and efficacy in clinical conditions. This study will have an 18 months inclusion period and 6 months of follow up. The principal objective is to assess the HAP/TCP biomaterial safety and to confirm clinically and histologically the good affinity of human epithelial cells for this material. Secondary objective is to demonstrate that the restoration of the normal nasal anatomy with the material re-establishes the nasal respiratory shape and function. Clinical data, questionnaires, and photos will be collected pre operatively and at day 4, 10, and month 2 and 6 after surgery. The endonasal biopsy and fiberoptic endoscopy will be realised at 2 and 6 months post operatively and will be supplementary to the routine care protocol of the surgeon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 18 and 60
- •Indication of tissue replacement in a nasal septum, which skeleton is lacking or non usable for patients having:
- •Paradoxal nasal obstruction with saddle nose type III and IV or flabby nose
- •Nasal obstruction with an obstacle caused by a moved multifracture skeleton
- •Written informed consent
- •Patient with social insurance
排除标准
- •Post-menopausal women : lack of efficient contraception (intra uterine dispositive or contraceptive pill)
- •Breast feeding or pregnant women
- •HIV or VHB or VHC seropositive subject
- •Inflammatory or infectious active rhino sinusitis
- •Nasal an sinus surgery or trauma ended from less than 8 months
- •Toxic medicated Rhinitis to vasoconstrictors
- •Diabetic : all type of diabetes (without or with therapy)
- •Non treated cardiac disease
- •Any contra indication to surgery
- •Any contra indication to the biomaterial use like evolutive infection, bone disease or local necrosis
- •Radiotherapy antecedent of the cephalic and cervical extremity
- •Local or regional therapy with corticoids currently, or stopped from less than 2 months
- •Patient participating to another study with an exclusion period still going on during pre-inclusion period
研究组 & 干预措施
Patient
干预措施: Rhinoplasty (Device)
结局指标
主要结局
Safety
时间窗: up to 6 months after surgery
Frequency and severity of expected Adverse and Severe Adverse Events, as material extrusion, infection (wall abscess), and chronic pathological inflammatory reaction, pain, epistaxis.
Epithelial cells affinity
时间窗: up to 6 months after surgery
macroscopic mucous membrane integrity (ciliated cells), absence of perforation, pathological analyses of biopsy to research sub epithelial infiltration, respiratory epithelial differentiation markers (HES, MOVAT pentachrome), immunohistochemistry (AB against cytokeratines 7, 8, 19, UEA1, MUC5AC) and MEB, MET analyses.
次要结局
- Performance with Internal and external nasal shape assessment(month 2 and 6 after surgery.)
- Performance with Functional Performance Assessment(pre operatively and post operatively at day 4, 10, and month 2 and 6 after surgery.)