Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT04003233
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT04003233
Study Brief:
Protocol Section:
NCT04003233