imited-efficacy testing of Spring Distraction System (SDS) and unilateral one-way rod (MID-C) for early onset scoliosis (UniPOWR study) - UniPOWR 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: 2024年4月15日

试验速览

暂无简介。

•1. Ambulant skeletally immature children, 6-12 yrs. of age, with open triradiate cartilages on X-ray
•2. Scoliosis diagnosis prior to the age 10
•3. Diagnosis of idiopathic or mild syndromic scoliosis (e.g. 22q11DS, Trisomy 21 or 9, Coffin-Siris)
•4. Progressive scoliosis qualified for growth system surgery
•5. One curve for treatment with an apex below Th5 and a proximal end vertebra below Th2
•6. The primary curve must be between 35 and 75 degrees coronal Cobb angle
•7. The primary curve must be non-rigid (i.e. the curve reduces on bending X-rays to <35 degrees or >30% of the curve)
•8. Normal or hypokyphotic sagittal alignment (Th5 -Th12 < 50 degrees) on lateral X-rays

•1. Patients with an obvious neuromuscular disease
•2. Patients that are severely mentally retarded
•3. Patients with a scoliosis that extends to the pelvis or the cervicothoracic region
•4. Patients with a main curve of more than 8 vertebra Cobb to Cobb
•5. Patients with a skeletal dysplasia that effects growth (e.g. achondroplasia, SED)
•6. Patients with a systemic disease which severely influences bone quality (e.g. osteogenesis imperfecta, metabolic diseases)
•7. Patients with soft tissue weakness (e.g. Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi)
•8. Patients with an active systemic disease such as JIA, HIV or oncologic treatment
•9. Patients with a previous surgical fusion of the spine
•10. Known allergy to titanium
•11. Patients weighing less than 11.4 kg or morbidly obese
•12. Patients that are expected to be lost to FU due to e.g. immigration
•13. Patient (or parents) that are expected to be non-compliant

发起方

niversitair Medisch Centrum Utrecht