A study on development of SPURLESK
- Conditions
- Patients after PVP for vertebral fractures
- Registration Number
- JPRN-jRCT1080225008
- Lead Sponsor
- ational Center for Global Health and Medicine Yumi Matsushita
- Brief Summary
The results of the questionnaire for the dorsal brace supporter were favorable. It became clear that there is a need for a flexible supporter that can be adapted to individual differences in the surgical site of the dorsal spine. Further improvements will be made in the future.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 4
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>confirmatory<br>We describe the mean, standard deviation, and histogram of the results from the questionnaire.
- Secondary Outcome Measures
Name Time Method safety<br>confirmatory<br>We describe the mean, standard deviation, and histogram of the patients' anthropometric data.