NL-OMON50347已完成不适用
imited-efficay testing of spring distraction system (SDS) and a bilateral one way rod (NEMOST) for early onset neuromuscular scoliosis (BiPOWR) - BiPOWR study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •- Niet ambulant
- •- Neuromuscular or syndromal scoliosis
- •- Progressive scoliosis indicated for bipolar fixation extending to the pelvis
- •- Diagnosis of scoliosis before age 10
- •- Patient under 12 and open triradiate cartilage (usually closes around 12
- •years for girls and 14 years for boys)
- •- Main curve proximal end vertebra below Th 3
- •- Non rigid curve (at least 25% decrease on bending X rays)
- •- Patients who have an indication for a primary surgery
排除标准
- •- Patients with closed triradiate cartilage
- •- Patients with a skeletal dysplasia that effects growth (Achondroplasia, SED)
- •- Patients with a systemic disease which severely influences bone quality e.g.
- •osteogenesis imperfecta, metabolic diseases
- •- Patients with soft tissue weakness (Ehler Danlos, Marfan, Neurofibromatosis,
- •Prader Willi)
- •- Patients that have a congenital anomaly of the spine of more than 5 vertebrae
- •- Patients with an active systemic disease such as JIA, HIV, oncologic treatment
- •- Patients with a previous surgical fusion of the spine
- •- Patients that are expected to be lost to FU due to e.g. immigration within 2
- •- Patients that have had a previous spine surgery.
研究者
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