The PRIORi-T Trial--Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation

This is a multi-center, prospective, randomized, post marketing clinical trial designed to
evaluate the clinical effectiveness of a minimally invasive procedure,
Radiofrequency-Targeted Vertebral Augmentation (RF-TVA), compared to Non Operative
Management (NOM) for the treatment of appropriately diagnosed, acute (≤ 8 weeks), painful,
osteoporotic vertebral compression fractures. Eligible subjects will be randomly allocated
to receive either RF-TVA or NOM in a 1:1 randomization ratio. Subjects will be followed for
12 months post procedure. Primary effectiveness will be determined by comparing the Visual
Analogue Scale for each treatment group for back pain from the baseline to the 1-month post
procedure visit and between treatment groups at 1-month.

Up to 15 sites will participate in this trial.

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.