Limited-efficacy Testing of Spring Distraction System (SDS) and a Bilateral One Way Rod (NEMOST) for Early Onset Neuromuscular Scoliosis (BiPOWR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- Limited-efficacy of SDS and NEMOST in terms of curve correction maintenance
研究概览
简要总结
The primary aim of this study is to investigate and describe the limited efficacy of the Spring Distraction System (SDS) and Bilateral One Way Rod (NEMOST) in maintaining curve reduction without repeat lengthening procedures and complications.
Secondary aims are to describe growth of the instrumented spine, health-related quality of life, and to compare both devices.
详细描述
Several innovative solutions have been developed to treat growing children with a severe scoliosis. One device (SDS) was developed internally at the department of orthopaedics UMC Utrecht in the Netherlands. The other device (NEMOST) was developed at the Necker Hospital in France.
This study is designed as a multicenter, limited-efficacy study using two prospective cohorts according a randomised clinical trial. The study will be performed in two centers (UMC Utrecht, Amsterdam UMC and Erasmus MC).
Primary endpoints are the limited-efficacy in terms of maintenance of curve correction and occurrence of SAEs related to the procedure. These data will be compared to a recently described cohort of patients that received a "standard treatment", the MGCR (Skov et al., 2017). Secondary endpoints include spinal- and implant growth, patient performance based on the EOSQ 24 questionnaire and surgical parameters.
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
The patient is blinded to the medical device until after surgery. This is done to prevent selection bias through withdrawal. Patients are unblinded post-operatively, to enable accurate patient counseling with radiographs, on which the implant can be clearly seen.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non 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
- •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. likely to immigrate within 1 year.
- •Patients that have had a previous spine surgery.
结局指标
主要结局
Limited-efficacy of SDS and NEMOST in terms of curve correction maintenance
时间窗: Until 1 year post-operatively
Changes in cobb angle on radiographs post-op and at 4 weeks, 3 months, 6 months and 12 months follow-up (FU). A maximum of 5 degrees increase will be the threshold to define maintenance.
Incidence of possible Treatment-Emergent Serious Adverse Events of SDS and NEMOST
时间窗: Until 1 year post-operatively
Reported treatment related Serious Adverse Events (SAEs) per-operatively and at 4 weeks, 3 months, 6 months and 12 months FU.
次要结局
- SDS vs. NEMOST with respect to blood loss during surgery(Until 1 year post-operatively)
- Limited-efficacy of SDS and NEMOST in terms of spinal length(Until 1 year post-operatively)
- SDS vs. NEMOST with respect to limited-efficacy in terms of curve correction maintenance(Until 1 year post-operatively)
- SDS vs. NEMOST with respect to limited-efficacy in terms of spinal length(Until 1 year post-operatively)
- SDS vs. NEMOST with respect to the development of the sagittale profile and instrumented thoracic kyphosis(Until 1 year post-operatively)
- SDS vs. NEMOST with respect to surgery time(Until 1 year post-operatively)
- SDS vs. NEMOST with respect to length of hospital stay(Until 1 year post-operatively)
- SDS vs. NEMOST with respect to the incidence of disease- or treatment-related Serious Adverse Events(Until 1 year post-operatively)
- SDS vs. NEMOST with respect to Quality Of Life (QOL) on the Early Onset Scoliosis Questionnaires (EOSQ-24)(Until 1 year post-operatively)
- SDS vs. NEMOST with respect to the effect on the development of the pelvic obliquity(Until 1 year post-operatively)
- SDS vs. NEMOST with respect to recovery time(Until 1 year post-operatively)
- SDS vs. NEMOST with respect to 3D development of the spine(Pre-operatively)
研究者
M.C. Kruyt, MD, PhD
Orthopaedic surgeon
UMC Utrecht