Multicenter Prospective Controlled Study in Cranioplasty Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 主要终点
- Safety
研究概览
简要总结
Multicenter, prospective, comparative, observational study with regular follow-up visits.
The project's aim is long-term follow-up of patients affected by large and complex craniolacuniae treated, in standard clinical practice, with CustomBone Service™ Cranial (porous bio-mimetic hydroxyapatite custom-made medical device for cranioplasty), autologous bone or polymethilmethacrylate customized prosthesis and to compare the clinical outcome and safety among the three treatments.
Elegibility to each treatment will respect the standard clinical practice. Each investigator will respect his own hospital criteria for cranial reconstruction.
Each centre's agreement to participate the study is totally voluntary.
The study sample size has not been defined on statistical criteria: the study population was set at 100 consecutive patients treated with cranioplasty reconstruction with one of the three foreseen group.
Each investigator will not be allowed to enrol more then 20 patients to avoid an enrolment imbalance between centres involved.
Primary study end-points are: evaluation of adverse event incidence after surgical treatment.
Secondary end-points are: quality of life improvement, evaluation of bone continuity restoration evaluated by CT scan analysis, neurological improvement.
详细描述
Cranioplasty surgery is necessary everytime a craniolacuniae has to be reconstructed to ensure protection to the central nervous system. Cranioplasty surgery is classified into first line surgery, due to traumatic events or degenerative pathologies, and second line treatment, when due to first treatment failure, for example because of autologous bone reabsorption/infection or other material reject.
Clinical evaluation scores Specific and validated clinical scores will be employed for End-points evaluation.
CT scan will required in the pre-operation visit and in the post-operation time during the follow up visits to evaluate the bone-implant osteointegration process and osteointegration will be evaluated applying a specific score.
Data have been recorded in a e-CRF with limited access, protected by personal password.
Data will always be collected in an anonymous way, subjects identity will always be undisclosed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients which need cranial reconstruction,
- •Cranioplasty reconstruction by autologous bone, hidroxyapatite or polymethylmethacrylate,
- •Patients of both sex in age range between 14 and 75 years old,
- •Craniolacuniae size > 25 cm2 ,
- •Patients affected by complex pathologies or fracture or infection of a previous implant.
- •Elegibility to CustomBone Service™ Cranial treatment will respect the product leaflet instructions.
- •Each investigator will respect his own medical centre internal inclusion criteria to cranial reconstruction.
排除标准
- •Patients affected by important emocoagulation pathologies,
- •Patients affected by mellitus diabetes,
- •Patients affected by autoimmune pathology,
- •Patients unable to intend,
- •Patients affected by immunodepression.
结局指标
主要结局
Safety
时间窗: 360 day after surgery
incidence of adverse event (infection, reabsorption, mobilization, fractures, dislocation) after surgical treatment
次要结局
- Efficacy(90, 180, 360, 720 days after the surgery)
研究者
Franco Servadei
Franco Servadei, Prof. MD
Azienda Ospedaliero-Universitaria di Parma