Lung Function, Osteoporotic Vertebral Compression Fractures
Conditions
Keywords
Improvement of lung function (FEV1, PEF), Visual Analog Scale, Oswestry Disability Index, Radiographs pre and post Op
Brief summary
Patients with vertebral fractures often have problems to straighten and as a consequence of impaired lung ventilation that leads to a impaired lung function. Furthermore, it comes to the sintering of the vertebra and a so-called hunchback. This also contributes to the poorer expansion of the lung. Pain is also caused by respiratory excursions of the chest which hinder the patients to use their entire lung volume. Kyphoplasty is designed to counter all these consequences of vertebral fractures by bringing stability to the fracture. In order to prove the thesis the results of lung function test (FEV1, PEF) are assessed.
Interventions
PROCEDURERadiofrequency Kyphoplasty
Radiofrequency kyphoplasty is a new form of surgical treatment. It injects an ultrahigh viscosity cement into the fractured vertebral body, using radiofrequency to achieve the proper consistency of the cement. This ultrahigh viscosity cement is designed to first restore proper height and alignment to the fractured vertebra and then to stabilize the fracture, thereby preventing further intravertebral motion and reducing pain. The RF-Kyphoplasty is standard of care in our hospital. It is FDA and CE approved.
Sponsors
University Hospital, Bonn
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* over 50 years * VAS over 49, ODI over 29 * radiographic evidence of A 1.1, 1.2, 1.3 fractures * patients mentally capable to sign informed consent
Exclusion criteria
* high-energy trauma * known tumor involvement * osteonecrotic fractures * burst fractures or pedicle fractures * previous surgical treatment for a vertebral body compression fracture * patient has paget's disease * BMI \> 35 * uncontrolled diabetes HbAc1c \> 7% * severe cardiopulmonary disease * Myelopathy * long-time steroid therapy
Countries
Germany
Contacts
Primary ContactRobert Pflugmacher, M.D.
Backup ContactRahel Bornemann
Outcome results
None listed