M80.08 M80.88
Conditions
Interventions
Group 1: Osteoporotic vertebral body fractures (A1.1-A1.3 and A3.1) are minimally invasive intravertebral stabilized with the OsseoFix system and followed up after 12 and 24 months and evaluated the c
Sponsors
Klinik für Orthopädie und Orthopädische Chirurgie Universitätsmedizin Greifswald
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: proven symptomatic lumbar or thoracic fresh osteoporotic vertebral fracture (A1.1-1.3 and A3.1) and an exhausted conservative treatment according to the current DVO guidelines
Exclusion criteria
Exclusion criteria: neurological deficits, due to posterior vertebral edge involvement that caused relevant spinal canal stenosis and known allergies to the contents of the Osseofix® systems or to bone cement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and radiological evaluation after 12 and 24 months postoperatively. Clinical evaluation by Oswestry Disability Index (ODI) and visual pain analog scale (VAS); imaging postoperative X-ray of relevant spinal with respect to the vertebral and spinal profile | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiological evaluation with imaging postoperative X-ray of relevant spinal region in two views and postoperative CT and X-ray of relevant spinal region in two views after 12 and 24 months for the evaluation of cementleakage,vertebral redressement, loss of height of the stabilized vertebra and adjacent fracture | — |
Countries
Germany
Contacts
Public ContactStephan Ender
Klinik für Wirbelsäulenchirurgie, Ev. Waldkrankenhaus Spandau-Berlin (vorher Klinik für Orthopädie und Orthopädische Chirurgie Universitätsmedizin Greifswald)
Outcome results
None listed