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:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT02370628
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Presence of:
* at least one and at most two acute VCF (\< 6 weeks) at levels caudate to T4, confirmed with physical examination and radiographic imaging
* if timing of the fracture is unclear, the following criteria are required for inclusion in the trial
1. an MRI scan showing edema at the fracture level(s) or
2. a bone scan showing increased uptake
* Physical examination showing axial back pain likely secondary to the VCF with restricted mobilization (score not maximum on any one of the following Barthel's Index items: transfer, mobility, bathing, dressing, stairs and toilet use)
* French or English speaking patient willing to return for follow-up or capable of following up with phone interviews if needed
Exclusion Criteria:
* Recent (\<30 days) major surgery causing debilitating pain
* Coagulopathy or thrombocytopenia precluding interventional treatment
* Inability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02370628
Study Brief:
Protocol Section:
NCT02370628