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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT05844358
Eligibility Criteria:
Inclusion Criteria:
1. those affected by degenerative disc disease needing a surgical treatment one/two levels with posterior approach to screw fixation
2. those who need a surgical procedure of lumbar spine stabilization according to Medacta device instruction for use from level L2 to level S1
3. those who signed consent form to participate to the study
4. Normal healthy patients or with mild systematic disease identified as patients with ASA score 1 or 2
5. Patients with BMI ≤ 35 kg/m2
6. non responsive or unsufficient resposive to non -invasive treatment such as analgesics
Exclusion Criteria:
1. Patients affected by lytic lystesis and degenerative lystesis with grade≥2 will be excluded
2. Patients \<18 years
3. Patient who is pregnant or intends to become pregnant during the study
4. Known substance or alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05844358
Study Brief:
Protocol Section:
NCT05844358