Limited-efficacy Testing of Spring Distraction System (SDS) and Unilateral One-way Rod (MID-C) for Early Onset Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- UMC Utrecht
- 试验地点
- 4
- 主要终点
- Limited-efficacy of SDS and MID-C in terms of curve correction maintenance: changes in cobb angle
研究概览
简要总结
The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of Early Onset Scoliosis (EOS) in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.
详细描述
Rationale: EOS is a severe and potentially life-threatening disorder since a disturbance of spinal development leads to impaired development of the trunk, with cardio-respiratory failure as a result, often early in adult life. Several innovative solutions have been developed to treat growing children with severe EOS. The SDS device was developed internally at the dpt. of orthopedics at the UMC Utrecht, the Netherlands, the MID-C device was developed by the company ApiFix Ltd.
Objective
The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of early onset scoliosis in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.
Study design: A feasibility study using two prospective cohorts according to an open label randomized clinical trial (RCT) design. The study will be done in two tertiary referral centers (UMC Utrecht and Amsterdam UMC). Primary endpoints are maintenance of curve correction as well as complications. These data will be compared to a recently described cohort of patients that received a "standard treatment" (Magnetically controlled growing rod (MCGR)). The same endpoints as well as secondary outcomes, will be compared between the two new treatments.
Study population: Children with idiopathic(-like) early onset scoliosis with an indication for a growing rod implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to the medical device till the surgery. After the surgery participants are able to see which medical device is implanted on X-rays.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulant skeletally immature children, 6-12 yrs. of age, with open triradiate cartilages on X-ray
- •Scoliosis diagnosis prior to the age 10
- •Diagnosis of idiopathic or mild syndromic scoliosis (e.g. 22q11DS, Trisomy 21 or 9, Coffin-Siris)
- •Progressive scoliosis qualified for growth system surgery
- •One curve for treatment with an apex below Th5 and a proximal end vertebra below Th2
- •The primary curve must be between 35 and 75 degrees coronal Cobb angle
- •The primary curve must be non-rigid (i.e. the curve reduces on bending X-rays to <35 degrees or reduces >30% )
- •Normal or hypokyphotic sagittal alignment (Th5 -Th12 < 50 degrees) on lateral X-rays
排除标准
- •Patients with an obvious neuromuscular disease
- •Patients that are severely mentally retarded
- •Patients with a scoliosis that extends to the pelvis or the cervicothoracic region
- •Patients with a main curve of more than 8 vertebra Cobb to Cobb
- •Patients with a skeletal dysplasia that effects growth (e.g. achondroplasia, SED)
- •Patients with a systemic disease which severely influences bone quality (e.g. osteogenesis imperfecta, metabolic diseases)
- •Patients with soft tissue weakness (e.g. Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi)
- •Patients with an active systemic disease such as Juvenile Idiopathic Arthritis, HIV or oncologic treatment
- •Patients with a previous surgical fusion of the spine
结局指标
主要结局
Limited-efficacy of SDS and MID-C in terms of curve correction maintenance: changes in cobb angle
时间窗: Until 1 year post-operative FU
changes in cobb angle on radiographs post-op and at 4 weeks, 3 months and 12 months follow-up (FU). A maximum of 5 degrees increase will be the threshold to define maintenance.
Incidence of Treatment-Emergent Serious Adverse Events of SDS and MID-C
时间窗: Until 1 year post-operative FU
Reported treatment related Serious Adverse Events (SAEs) per-operatively and at 4 weeks, 3 months and 12 months FU.
次要结局
- Limited-efficacy of SDS and MID-C in terms of spinal length(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to limited-efficacy in terms of curve correction maintenance(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to limited-efficacy in terms of spinal length(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to the incidence of Treatment-Emergent Serious Adverse Events(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to surgery time(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to blood loss during surgery(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to length of hospital stay(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to recovery time(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to bone density(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to Quality Of Life (QOL) on the Early Onset Scoliosis Questionnaires (EOSQ-24)(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to flexibility of the spine(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to 3D development of the spine(Until 1 year post-operative FU)
- SDS vs. MID-C with respect to patient appearance(Until 1 year post-operative FU)
研究者
M.C. Kruyt, MD, PhD
Principal Investigator
UMC Utrecht