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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05815251
Eligibility Criteria:
Inclusion Criteria:
* Presence of osteoporotic vertebral fracture occurred within the previous 6 weeks and documented by CT, MRI, or X-ray in relation to the diagnostic pathway the patient underwent
* Patients with fractures according to AO Spine-DGOU OF2, OF3 and OF4 classification are enrollable limited to cases in which soma height loss is less than 60% and in the absence of vertical split type pincer fracture.
* Diagnosis of osteoporosis preceding or concurrent with fracture occurrence, regardless of current therapy
* Favorable for inclusion in the study with signed informed consent, available for follow-up up to 1 year.
* Availability of adequate preoperative radiologic documentation: CT or MRI of the lumbar spine; RX required for evaluation of kyphosis.
* Availability of adequate and comprehensive clinical information including presence of ODI score, MRQ, VAS.
Exclusion Criteria:
* Presence of oncologic, metabolic, or endocrinologic diseases related to bone fragility
* Age \< 55 years
* Previous treatment of arthrodesis, vertebroplasty, or percutaneous kyphoplasty for previous fractures
* Presence of neurological deficits in the lower limbs medullary or radicular prior to fracture occurrence
* Unavailability for follow-up for at least 1 year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT05815251
Study Brief:
Protocol Section:
NCT05815251