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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT03369158
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 12 years
* patients suffering from coronal or sagittal spinal deformities that will undergo a surgical treatment with a posterior approach and pedicle screws placement
* Patients suitable to undergo spinal stabilization (according to the label indication/contraindications)
* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained when indication to surgery is confirmed.
Exclusion Criteria:
* Patient with congenital spinal deformity (emeverebre, vertebra wedge, vertebrate butterfly, congenital bar, vertebra block)
* Patients with a previous fusion of the spine in the region where screws will be inserted
* Patients with any allergy to the device implanted
* Patients who will be not able to provide their written consent to the study participation
* Patients who are incapable of understanding and wanting
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03369158
Study Brief:
Protocol Section:
NCT03369158