Evaluation of the Use of Resources and Costs With O-arm in Brain Stimulation Deep Surgeries and Complex Back Surgeries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups)
研究概览
简要总结
Evaluation of the use of resources and costs with O-arm in deep brain stimulation (DBS) surgeries and complex back surgeries
详细描述
To measure the use of health resources in application A (with DBS) and in application B (vertebral fusions), in patients in the intervention group with O-arm and in the control group (usual care without O-arm) with the cost in each phase (pre-surgical, surgical, post-surgical and follow-up at 6 months (RAQUIS) and at 12 months (DBS))
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years.
- •Signed informed consent.
- •Patients with indication for DBS surgery for movement disorders, epilepsy and obsessive-compulsive disorder, or for cervical, dorsal or lumbar fusion surgery levels 1,2 and 3 in a degenerative disease
排除标准
- •Patients who have had pediatric instrumented surgery.
- •Patients in which the pedicle screws are inserted for neoplasia or other disease.
研究组 & 干预措施
O-Arm in deep brain stimulation surgeries (DBS)
Use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)
干预措施: Device O-Arm in DBS (Procedure)
Control group Not O-Arm in deep brain stimulation surgeries
Not use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)
干预措施: Not device O-Arm in DBS (Procedure)
O-Arm in complex back surgeries (RAQUIS)
Use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)
干预措施: Device O-Arm in RAQUIS (Procedure)
Control group Not O-Arm in complex back surgeries (RAQUIS)
Not use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)
干预措施: Not device O-Arm in RAQUIS (Procedure)
结局指标
主要结局
Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups)
时间窗: 12 months
Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with vertebral fusions (O-Arm and without O-Arm groups)
时间窗: 6 months
次要结局
- Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention(12 months)
- Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery(6 months)
- Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery(12 months)
- Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary(12 months)
- Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery(6 months)
- Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery(12 months)
- Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention(6 months)