| Eligibility |
Inclusion Criteria:
- 5o years of age.
- Legal US citizen with ability to read and write.
- Acute painful fracture (=2 months) between T6 to L5 as evidenced by plain radiography,
CT / Bone scan, and/or magnetic resonance imaging.
- Subject is...
- Non-Standard Treatment:
- Inability to tolerate prolonged conservative care due to intractable pain
(VAS 70/100) with maximum tolerated medication for at least 2 weeks, but
less than 6 weeks; OR
- Inability to tolerate prolonged immobilization due to other comorbid
conditions aggravated by immobility for at least 2 weeks, but less than 6
weeks; OR
- Intolerance of or adverse reaction to available pain medications for at
least 2 weeks, but less than 6 weeks; OR
- Hospitalization secondary to pain for at least 2 weeks, but less than 6
weeks.
- Standard Treatment:
- Has undergone at least 6 weeks of conservative care.
- Have a self assessment VAS score = 50 mm at the Baseline visit.
- Have 30% or greater disability score on ODI at the Baseline visit.
- Anterior wedge deformity with no less than 5% and no more than 75% loss of anterior
cortical height as compared to the posterior cortical height of the same vertebral
body.
- Bone mineral density (BMD) T-score of -1.5 or less, as determined by a DEXA scan.
- Intact posterior cortical vertebral body wall.
- Type A compression fractures according to AO classification of spinal vertebral
fractures.
- If a transpedicular approach is utilized the pedicle diameter must be equal to or
greater than 6.5 mm; however, if an extrapedicular approach is utilized there is not a
minimum pedicle width requirement.
- Subject is willing and able to provide informed consent and agrees to release medical
information for purposes of this study (HIPAA authorization) and to return for
scheduled follow-up evaluations.
Exclusion Criteria:
- Significant vertebral collapse defined as more than 75% of original vertebral height
or less than 5% or a burst or pedicle fracture with posterior cortical wall
disruption.
- Presence of healed fracture at the intended treatment level(s) based on a CT / bone
scan or MRI.
- Compression fractures requiring treatment at 3 or more levels.
- Spinal/Foraminal canal compromised.
- Significant deformity/instability indicated by:
- Segmental kyphosis > 30 degrees, or
- translation > 4 mm.
- VAS back pain score of < 50 mm.
- ODI score of < 30%.
- Have a documented active systemic or local infection, such as AIDS, hepatitis, with a
WBC greater than 11.5 and a temperature greater than 101.5°F.
- Spinal surgery in the thoracic and/or lumbar region within the past year
- Previous kyphoplasty or vertebroplasty at involved level or level above or below
treated level.
- Spinal arthrodesis within 2 adjacent levels of fracture.
- Non-ambulatory prior to fracture.
- Greater than Grade 1 spondylolisthesis at level of fracture.
- Scoliosis > 10 degrees.
- BMI > 40.
- Severe cardiopulmonary deficiencies.
- Pregnant.
- Type I or II diabetes without controlled A1C level.
- Achondrogenesis disorders.
- Active malignancy, hemangiomas at the operative level(s), or multiple myeloma.
- No generally accepted medical contraindication to spinal surgery and/or general
anesthesia, such as coagulopathy with a threshold for INR at 1.5 or less, and platelet
count 100,000.
- A life expectancy less than the study duration or undergoing palliative care.
- Trauma injuries aside from vertebral compression fracture(s).
- Injuries that violate the posterior vertebral cortex and/or posterior column.
- Active litigation.
- Currently on workman's compensation.
- Autoimmune disorders.
- Non-spine pain that requires daily Opioids.
- Systemic long-term steroid use - greater than 6 months.
- Active multiple sclerosis or neurologic deficit caudal to fracture.
- Currently an alcohol, solvent, or drug abuser.
- Psychiatric or cognitive impairment that, in the opinion of the investigator, would
interfere with the subject's ability to comply with the study requirements.
- History of allergies to any of the device components including but not limited to
commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide
(ZrO2)
- Incarcerated.
- Are currently participating in another investigational study.
- Having had another device implanted in the thoracic and/or lumbar area that would
interfere with the surgical approach, study device, or follow-up evaluations.
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