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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT01480167
Eligibility Criteria:
Inclusion Criteria:
1. Subject is ≥ 21 and ≤ 90 years of age.
2. Subject has one (1) to three (3) painful vertebral compression fracture(s) at T5-L5 due to primary or secondary osteoporosis (i.e. non-malignant) and recent history of sudden onset of pain in area of index vertebra (e).
3. Subject's index vertebra (e) is confirmed as the active source of back pain as evidenced by concordant pain and bone marrow edema via magnetic resonance imaging (MRI) or Computerized Tomography (CT) plus bone scan.
4. Subject has a history of vertebral fracture-related back pain ≤ 8 weeks old at time of enrollment (confirmed by medical history).
5. Subject has a pain related VAS score ≥ 5 on a scale of 0 to 10 at time of enrollment. Pain represents the worst level of back pain while standing, walking or elevating from chair, bed, or car during the preceding 24 hours associated with the index vertebra (e).
6. Subject has a Roland Morris Disability Questionnaire (RDQ) score ≥ 10 on scale of 0 to 24 at time of enrollment.
7. Subject is a suitable candidate for minimally invasive VCF procedure.
8. Subject has sufficient mental and physical capacity to comply with the Investigational Plan requirements and is willing and able to provide informed consent; agrees to release medical information for the purposes of this study; and agrees to comply with the Investigational Plan requirements and return for specified follow-up evaluations.
9. Subject is a male; a documented infertile female (either postmenopausal or surgical contraception); or is a non-pregnant, non-lactating female of childbearing potential who agrees to use a medically accepted method of birth control throughout the duration of the trial.
Exclusion Criteria:
1. Subject's VCF morphology is deemed unsuitable for RF-TVA in the judgment of the Investigator.
2. Subject requires additional non-kyphoplasty or vertebroplasty surgical treatment for the index fracture.
3. Subject has surgery to the spine planned for at least one (1) month following enrollment.
4. Subject has high-energy trauma-related and/or, non-osteoporotic vertebral fractures.
5. Subject has a spinal cord compression or significant canal compromise requiring decompression, in the judgment of the investigator.
6. Subject has a neurologic deficit associated with the vertebral level(s) to be treated that is more severe than radiculopathy (e.g. myelopathy, cauda equina syndrome).
7. Subject has irreversible coagulopathy or bleeding disorder.
8. Subject requires, at time of enrollment, the use of high-dose steroids (e.g. ≥ 100 mg prednisone or 20 mg dexamethasone per day), intravenous (IV) pain medication, or nerve block to control chronic back pain unrelated to index VCF(s).
9. Subject has significant clinical co-morbidities that may potentially interfere with the collection of data concerning pain and function.
10. Subject has a known allergy to device materials (e.g. polymethylmethacrylate (PMMA) or barium).
11. Subject has a contraindication to local or general anesthesia.
12. Subject has a medical and/or surgical condition contrary to the kyphoplasty or vertebroplasty procedure (e.g. presence of local or systemic infection).
13. Subject is receiving Worker's Compensation.
14. Subject is a prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT01480167
Study Brief:
Protocol Section:
NCT01480167