Clinical Observations and Testing - Nanostructural Bioceramics: Advances in Chemically Bonded Ceramics - page 120

4 Pain corresponding to at least 5 (50) out of 10 (100) on a VAS

scale

5 Oedema in the vertebra as seen at MRI

6 Substantial requirement of analgesics

7 Signed written informed consent

Abbreviation : MRI, magnetic resonance imaging.

Table 12.11 Exclusion criteria

Criteria Description
1 Previous spinal surgery
2 Neurological deficit or radiculopathy associated with the level
to be treated
3 Complete vertebral compression/collapse
4 Disabling back pain secondary to causes other than the acute
fracture
5 Malignancy
6 Above reference value of serum creatinine
7 Uncorrectable coagulation disorder
8 Immunological deficit
9

Active infections of any kind

10 MRI contraindication

11 Participation in other clinical studies within the last 30 days

12 Other clinical conditions that makes the patient unsuitable for

PVP

13 Disruptions and other kinds of fractures in the area under study

A complete study comprises several aspects related to baseline
actions, imaging, questionnaires, safety, surgery, and laboratory
work. A time table of the overall study is presented in Table 12.12.
Descriptions of tools used in the evaluation are also described in
more detail below.

Visual Analogue Scale
Pain relief was measured using a VAS graded from 0 to 10 (0-100 mm)
[18]. The principal investigator (PI) was to ask the patient,

How