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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT07026305
Eligibility Criteria:
Inclusion Criteria:
* Surgical indication determined by:
* Lower back pain and/or lower extremity pain for more than 3 months.
* Pain refractory to conservative medical management (analgesics, physical therapy, epidural block).
* Clinical criterion of neurogenic claudication defined as a score ≥11 on the N-CLASS scale.
* Preoperative magnetic resonance imaging (MRI) showing lumbar canal stenosis.
* Patient consents to the proposed surgical intervention.
* Patient agrees to participate in the study by signing the informed consent form.
Exclusion Criteria:
* Foraminal or lateral recess stenosis.
* Symptomatic disc herniation at the segment to be treated.
* Spondylolisthesis \> Grade I (Meyerding) (translation \>25% of the vertebra) or spondylolysis.
* Radiological instability defined as \>5 mm of anteroposterior translation on dynamic flexion-extension spine X-rays.
* Scoliosis with Cobb angle \>30°.
* Compression fracture at the level to be treated.
* Prior surgery at the same segment to be treated.
* Prior infection at the segment to be treated.
* Contraindication for MRI.
* Diagnosis of major depressive disorder or dysthymia according to DSM-V criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT07026305
Study Brief:
Protocol Section:
NCT07026305