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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT03407560
Eligibility Criteria:
Inclusion Criteria:
Patients who have provided consent to the processing of personal data;
* Patients over the age of 18;
* Patients who require posterolateral fusion of lumbosacral tract (L1- S1);
* Patients suffering from traumatic and degenerative diseases of the spine, such as lumbar stenosis, spondylolysis and spondylolisthesis, degenerative disc disease;
* Patients who agree to participate in the program of visits required by the Protocol.
Exclusion Criteria:
Patients affected by:
* systemic or localized infection
* inflammatory or autoimmune disease
* hypercalcemia
* coagulation disorders
* metabolic disorders
* insulin dependent diabetes
* alterations or complications of thyroid function
* allergy to calcium phosphate
* declared allergies to medications and / or medical device
* tumor diseases and / or infectious diseases of the spine
* active neoplasia
* Patients who abuse of alcohol or drugs
* Patients in the alleged pregnancy or confirmed
* Patients on medication that causes abnormal bone regeneration (eg chemotherapy)
* Already operated patients (revision surgery)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03407560
Study Brief:
Protocol Section:
NCT03407560