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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT00819832
Eligibility Criteria:
Inclusion Criteria:
1. Patient is \>18 years old.
2. Patient is a candidate for standard vertebroplasty or Kyphoplasty with reasonable safety, as determined by the physician performing the procedure.
3. Patient is medically fit to undergo conscious sedation.
4. Patient is able to understand and give consent to participation in the study.
5. Patient presents with back pain \>= 50 (on a 0-100 VAS scale).
6. Patient presents with a vertebral compression fracture believed to be due to malignancy.
7. Patient agrees to undergo, prior to the procedure, both magnetic resonance imaging (MRI, within 45 days of the planned procedure) and computed tomography (CT, within 14 days of the procedure). If MRI is contraindicated (due to pacemakers, intracranial ferromagnetic metal, etc), imaging with a nuclear medicine bone scan could be used as an alternative. CT remains mandated as a planning modality for all cases.
8. Patient has a life expectancy of at least 4 months.
9. Patient agrees to participate in the clinical study and to complete all required visits and evaluations.
10. Patient's vertebrae can safely be accessed with an 8 Gauge Cannula.
11. Suitable test for Circulating Tumor Cell Burden (CTCB) is available.
Exclusion Criteria:
1. Patient has unfavorable surgical anatomy to indicate that the patient could not be safely treated in any one of the four surgical groups if the patient was randomized to that group.
2. Patient has uncorrectable coagulopathy.
3. The metastatic lesions are determined to be blastic in nature and contain such sclerotic bone that the fracture site cannot adequately be accessed.
4. Vertebral compression fractures are present at multiple-levels and more than 2 levels must be treated during the same surgery (patients who have multi-level disease can still be enrolled provided no more than 2 levels be treated at one occasion).
5. Patient has significant risk of procedure-related complications due to potential interactions with devices or materials used in the procedures, i.e., Pacemaker implant or Allergy (e.g., to cement, cannula metal, contrast medium, etc.)
6. Patient is unable to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00819832
Study Brief:
Protocol Section:
NCT00819832