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:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT06670404
Eligibility Criteria:
Inclusion Criteria:
* Patients \>18 years.
* Patients requiring vertebroplasty for the fixation of symptomatic pathological fractures of the thoracic or lumbar vertebral body resulting from osteoporosis or tumor.
* Symptomatic vertebral compression fracture(s) confirmed by MRI with bone marrow oedema on T2/STIR sequences.
* Diagnosis of osteoporosis (clinically and confirmed on DXA with quantifiable BMD) or pathological fracture due to tumor
* Patients with 1 or more vertebral compression fractures of the thoracic or lumbar spine Note: Patients with a current vertebral compression fracture who also have a previous history of vertebral compression fractures of the thoracic or lumbar spine may be included.
Study Specific Inclusion Criterion • Signed informed consent
Exclusion Criteria:
* Infection
* Vertebral body collapse to less than 1/3 (33%) of original height
* Vertebral plana (\>90% vertebral body collapse)
* Spinal stenosis (retro pulsed fragments).
* Unstable spine warranting surgical stabilization
* Prophylactic treatment of any vertebrae with vertebroplasty
* Irreversible life threating bleeding disorders
* End stage kidney disease
* Drug dependence (IVDU)
* Pregnancy
Study Specific Exclusion Criterion:
• Unable or unwilling to follow the standard of care prescribed follow-up visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06670404
Study Brief:
Protocol Section:
NCT06670404