Evaluation of the Efficiency of Nemost Growing Spine Device Associated With Physiotherapy in the Surgical Treatment of Progressive Scoliosis of the Child
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- No surgical reoperation
研究概览
简要总结
The purpose of this study is to evaluate the performance of the device "NEMOST" on maintaining of the correction of the scoliosis with growth preservation and avoiding iterative surgeries.
Objective of this study is to evaluate the performance of the growing device "NEMOST" associated to physiotherapy at 12 months postoperatively in patients treated for progressive scoliosis and to evaluate its safety.
详细描述
A number of scoliosis in the child remain progressive despite conservative treatment well conducted. Nowadays the most used treatment is early surgical treatment by the spinal instrumentation without graft called "growing rods". The use of growing rods in patients with progressive scoliosis requires several repeated surgeries (every 6 to 12 months) in order to follow the growth of children. These repeated surgeries lead to a significant increased risk of complications, that's why many teams around the world have been seeking solutions which allow to obtain a rod expansion without repeated surgery.
The purpose of our study is the evaluation of the use of medical device that will perform the correction of scoliosis and, at the same time, preserve the growth of the child's spine. In addition, the purpose of clinical investigation is to test the theory that distraction effort may be exercised without surgery thanks to traction manoeuvres and physiotherapy. This could allow to obtain in patients with progressive scoliosis, correction of spinal deformity while avoiding many repeated surgeries. Our reference device is growing rod "NEMOST". When implanted, NEMOST rod is immediately turned on, for correcting and maintaining the correction of spinal deformity. After implantation, depending on development in Cobb angle, one or more elongations can be made by sliding the notched portion of the rod in its tunnel by a distraction effort (traction equipments and physiotherapy).
Therefore, the growth device NEMOST will allow to continue, on request, the correction of spinal deformity by performing a distraction by external manoeuvres on the notched part without the need for surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient from 5 to 15 years old
- •Patient with neuromuscular scoliosis or progressive scoliosis resistant to conservative treatment
- •Patient with an indication of first-line surgery without graft
- •Patient with low skeletal maturity (Risser test = 0 and triradiate growth cartilages still open)
- •Signing of the consent by the holder (s) of parental authority and the investigator
- •Affiliated patient to a health service or entitled patient
排除标准
- •Patient with a history of spinal surgery
- •Patient weighing more than 30 kg and with progressive scoliosis other than neuromuscular
- •Patient with contra-indication to Nemost device, that is to say:
- •Inflammation or acute Infection, local or systemic,
- •Allergy or intolerance titanium or polyetheretherketone,
- •Pathology or poor bone quality might compromise the attachment of the device,
- •Nonreducible Scoliosis,
- •Skin Substance insufficient to cover the wound,
- •Pathological Obesity,
- •Fracture and / or spinal tumor,
- •Patient whose behavior presents a risk of failure for the device.
结局指标
主要结局
No surgical reoperation
时间窗: 12 months
The lack of indication of surgical reoperations means that the correction of scoliosis is satisfactory and the growth had been maintained
No worsening of Cobb angle by more than 15 degrees since the initial correction
时间窗: 12 months
A worsening of the Cobb angle by more than 15 ° since the initial correction is considered an indication of reoperation
次要结局
- Cobb angle(6 months)
- T1-T12 segment and T1-S1 segment(18 months)
- Weight (kg)(Every month for 18 months)
- Cobb angle (degree)(18 months)
- reserve rod (mm)(18 months)
- respiratory function(18 months)
- Safety of NEMOST(18 months)
- Pelvic obliquity (mm)(18 months)