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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT03580434
Eligibility Criteria:
Inclusion Criteria :
* Adult male and female patients
* Treatment of vertebral compression fracture (type A.1, some A.2 and rarely A.3 Magerl classification)
* Due to osteoporosis or tumorous lesions,
* Located in the thoracic and/or lumbar spine from T9 to L5.
* One unique vertebral fracture to be treated with the device
* Pain \> 4
* ASA \> 5
* For osteoporotic patient, fail in conservative treatment (8 days of antalgic medication Level III) and recent fracture (less than 6 weeks).
Exclusion Criteria:
* Unstable fractures or neoplasms with posterior involvement
* Nonmobile fractures
* Damages of the pedicles or posterior wall
* Less than one third of the original vertebral body height remaining
* Spinal canal stenosis (\>20%)
* Neurologic signs or symptoms related to the compression fracture or impeding pathological fracture
* Patient clearly improving on conservative treatment
* Pregnancy, breastfeeding
* Any contra-indication / allergy to implant material or cement
* Any previous surgical treatment (material or cement) in the targeted vertebra
* Systemic infection or infection located in the spine
* Any medical condition including but not limited to anaemia, coagulation disorders, fibromyalgia, algoneurodystrophy, Paget's disease, uncontrolled diabetes that would preclude the patient from having surgery or would impede the benefit of surgery
* Patient under the age of majority
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03580434
Study Brief:
Protocol Section:
NCT03580434