Swiss Prospective Autologous Bone Flap Resorption Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Incidence of a relevant bone resorption within 12 months after reimplantation
研究概览
简要总结
The complications after reimplantation of cryoconserved autologous bone flaps are reported inhomogeniously in the literature. Especially the incidence of bone flap resorption varies from 0% to about 30%. More recent retrospective studies seem to find higher resorption rates and thus suggest to implant artificial bone replacements from the start. The Swiss Prospective Autologous bone Resorption Study is the first propspective observational study designed to determine the true incidence of autologous bone resorption.
详细描述
Patients undergoing decompressive craniectomy and delayed reimplantation of the cryoconserved autologous bone flap are included in a clinical and image-based follow-up to identify cases and severity of bone flap resorption.
The explanted autologous bone flaps are cryoconserved and reimplanted at a time-point defined by the surgeon according to standards of the participating hospital. The fixation of the bone flap is also performed according to the surgeon's decision.
A cranial CT is performed within one week after reimplantation to define a baseline.
A second, only clinical, follow-up will take place within 2 months after reimplantation.
Two more follow-ups including photodocumentation of the cranial and facial symmetry (portrait and profile) and cranial CT will take place 12 and 24 months after reimplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients after hemicraniectomy or bifrontal craniectomy
- •age 18-99 y/o
- •ability to understand and sign informed consent (alternatively, legal representative may sign)
排除标准
- •bone flap not fit for reimplantation
- •no cryoconservation performed but other technique
- •pregnancy
- •patient's death
结局指标
主要结局
Incidence of a relevant bone resorption within 12 months after reimplantation
时间窗: 12 months
The extent of bone flap resorption is analyzed as well objectivela as subjectivels: objective criteria: Volumetric reconstruction of the bone flap from the CT scans and subtration of the actual bone flap volume from the 3D model at the basline-timepoint directly after reimplantation subjective: a bone flap resorption score is validated
次要结局
- Fluid collections and bleedings(2, 12 and 24 months after reimplantation)
- Incidence of an indication for surgical revision(12 and 24 months after reimplantation)
- Death(2, 12 and 24 months after reimplantation)
- timepoint between explantation and reimplantation(2, 12 and 24 months after reimplantation)
- fragmentation of the bone flap(2, 12 and 24 months after reimplantation)
- pathologies leading to explantation of the bone flap (hemicraniectomy)(2, 12 and 24 months after reimplantation)
- Infections(2, 12 and 24 months after reimplantation)
- Hydrocephalus(2, 12 and 24 months after reimplantation)
- patient age(2, 12 and 24 months after reimplantation)
- Temporal muscle atrophy(2, 12 and 24 months after reimplantation)
- temperature used for cryoconservation(2, 12 and 24 months after reimplantation)