Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures

Exclusion Criteria

• •Patient
• •1. Substance use disorders (incl. tobacco abuse \>20 cigarettes/day) and alcohol abuse disorders within the last 2 years before randomization.
• •2. BMI \> 35
• •3. Permanent or progressive neurologic deficits (incl. upper motor neuron disease and myelopathy)
• •4. Known Creutzfeldt Jacob Disease
• •5. Systemic infections:
• •* Known infection with human immunodeficiency virus (HIV) or, hepatitis B or C requiring treatment
• •* Any active infection requiring the use of parenteral anti-microbial agents or that is \> grade 2 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
• •6. Rheumatoid arthritis or known disorders of bone metabolism (excl. osteopenia/osteoporosis, Vitamin D deficiency)
• •7. Radiation therapy of the spine in medical history
• •8. Contraindications to pedicle screw and rod stabilization
• •9. Breast feeding, pregnancy or child-bearing potential (female patients of childbearing potential and male patients with a partner of child bearing potential must agree to use a highly effective contraceptive method).
• •10. A compromised immune system or a therapy with systemic corticosteroids or immunosuppressants
• •11. Active malignancy or history of malignancy (excl. Basalioma as a semi-malignant tumor) \<2 years ago from time of randomization
• •12. Known allergy to any component of the investigational device
• •13. History of severe allergy, anaphylactic reactions and hypersensitivity reactions experienced in previous surgical interventions.
• •14. Other concurrent severe and/or uncontrolled medical conditions (e.g. insufficiently treated diabetes (HbA1c \> 8 %), active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
• •15. Participation in other clinical investigations for drugs or devices
• •Fracture
• •16. Fracture age \> 3 months
• •17. Major surgery to the spine planned for at least 12 months following enrolment