OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture (OsseoFix)

This is an interventional treatment trial for Vertebral Compression Fractures focused on measuring VCF Read More

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.