Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients Using the Nemost-AIS System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic tilt)
研究概览
简要总结
The primary objective of the study is to monitor the effectiveness of a minimal invasive non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the scoliotic curve in growing patients suffering from progressive adolescent idiopathic scoliosis (AIS) who have failed conservative treatment.
详细描述
Scoliosis is a complex three-dimensional deformity of the spine, which occurs primarily in growing children and adolescents. In adolescent idiopathic scoliosis (AIS), the cause is unknown. Children with severe and progressive scoliosis, if left untreated, are at risk of rapid and severe spinal deformity progression, which can result in a decrease of pulmonary function, poor cosmetic result and poor quality of life.
Treatment options in AIS depend on curve severity and remaining growth potential, and include intensive brace treatment for smaller curvatures whereas surgical correction and spinal fusion is advocated for more severe curves. Growing rods are used for severe early infantile deformities or early onset scoliosis (EOS).
Bracing, by using a rigid plastic orthosis, is currently the primary therapy to prevent curve progression in mild curves up to 45 degrees and skeletal immature patients. Most braces are recommended to be worn for 18-23 hours per day during several years (until skeletal maturity has been reached). This may cause a high level of physical discomfort and emotional and psychological stress in these patients, and failure of brace treatment therefore is common.
Surgical therapy for AIS is recommended in severe progressive curvatures. Surgical treatment includes correction of the spinal curvature by using multisegmental screw fixation and posterior spinal fusion of the thoracolumbar spine. Complete posterior spinal fusion, however, lacks the possibilities for future adaptation of natural changes in spinal balance and posture.
Currently, growing rods systems are used as a posterior spinal implant to allow growth of the spine and thorax and limit progression of the scoliosis in young patients with early onset scoliosis. Growing rods systems are distractible spinal implants, with bipolar anchorage fixations to the upper and lower part of the spine, using posterior spinal instrumentation such as hooks and pedicle screws.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent idiopathic scoliosis ;
- •Primary Cobb angle greater than 30°;
- •Failed non-operative treatment defined as progression of the curve greater than 5° per year at any time;
- •Skeletally immature (Risser grade* ≤2 and Skeletal age of hand and wrist X-rays ≤14y);
- •In girl, either pre-menarchal or post-menarchal by no more than 1 year;
- •Age over 10 years;
- •Non rigid curve;
- •All Lenke type;
- •No previous spine surgery.
排除标准
- •Non-idiopathic scoliosis: musculoskeletal or neurologic conditions responsible for cause of the spine curvature (i.e. neuromuscular, congenital or syndromic scoliosis);
- •History of previous spine surgery;
- •Risser sign >2;
- •Disease or deformity likely to affect the stability of the device (i.e. inadequate anatomy of pedicles, trauma or tumor in fixation region, severe osteoporosis, bone destruction or poor bone quality);
- •Non-reductible scoliosis;
- •Known allergy or intolerance to one of the device material;
- •Acute or chronic infections, local or systemic;
- •Absence or insufficience of covering tissues;
- •Pathological obesity.
结局指标
主要结局
Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic tilt)
时间窗: 2 years
degrees
T1-S1 length on radiograph
时间窗: 2 years
length (cm)
(Serious) Adverse Event
时间窗: 2 years
complications
Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal junctional angle)
时间窗: 2 years
Cobb angle (degrees)
Coronal balance (Correction of the primary curvature on radiograph
时间窗: 2 years
Cobb angle (degrees)
instrument segment length on radiograph
时间窗: 2 years
length (cm)
次要结局
- Vertebral rotation(2 years)
- Patient Reported Outcome (PRO(2 years)
研究者
BJ van Royen
clinical professor, principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)