Patients after PVP for vertebral fractures
Conditions
Interventions
investigational material(s)
Generic name etc : A casual underwear covering the protruded spinous processes
INN of investigational material :
Therapeutic category code :
Dosage and Administration for
Sponsors
National Center for Global Health and Medicine Yumi Matsushita
National Hospital Organization Kyushu Medical Center Tomoyuki Noguchi
National Center for Global Health and Medicine Yoshitaka Shida
National Institute of Public Health Tetsuji Yokoyama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult in- or out-patients after PVP for vertebral fractures at the collaboration institutions between the date of Institutional Review Board approval and March 31, 2021 who have ability or a nursing care enough that they can try on SPURLESK for a 5-day and answer questionnaires, and hand in the questionnares and SPURLESK at the timing of regular post-operative follow-up.
Exclusion criteria
Exclusion criteria: Patients with cognitive decline who have difficulty responding to the questionnaires for wearing SPURLESK. Patients who are judged to be difficult to wear properly despite the fact that the principal investigator, conducting investigator, or co-investigator explain the precautions for wearing SPURLEST with the precaution document are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety confirmatory We describe the mean, standard deviation, and histogram of the results from the questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety confirmatory We describe the mean, standard deviation, and histogram of the patients' anthropometric data. | — |
Countries
Japan
Outcome results
None listed