UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041040 |
|---|---|
| Receipt number | R000046604 |
| Scientific Title | Efficacy of early indication of Balloon kyphoplasty for thoracolumbar osteoporotic vertebral body fracture |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/07/15 09:33:03 |
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Basic information
Public title
Efficacy of early indication of Balloon kyphoplasty for thoracolumbar osteoporotic vertebral body fracture
Acronym
Efficacy of early indication of Balloon kyphoplasty for thoracolumbar osteoporotic vertebral body fracture
Scientific Title
Efficacy of early indication of Balloon kyphoplasty for thoracolumbar osteoporotic vertebral body fracture
Scientific Title:Acronym
Efficacy of early indication of Balloon kyphoplasty for thoracolumbar osteoporotic vertebral body fracture
Region
| Japan |
Condition
Condition
Osteoporotic vertebral fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Osteoporotic vertebral fracture (OVF) is one of the factors that require long-term care, but conventionally, rehabilitation is started after long-term bed rest. In recent years, percutaneous vertebroplasty (Balloon Kyphoplasty: BKP) has been widely used with public insurance since January 2011 for cases in which healing of vertebral body fractures is prolonged. Since BKP is expected to be less invasive and can be expected to reduce pain early, it can be expected to return to society sooner, so the treatment is of great significance, but changes in ADL due to early adaptation, changes in the degree of long-term care, etc. are still unknown. The purpose of this study is to examine the effectiveness of early adaptation by observing the postoperative course by returning to society early by applying BKP treatment early.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain Numerical Rating Scale (NRS) NRS improvement 12 months after admission was improved by 50% or more compared to the time of injury (effective rate of BKP treatment)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 70 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Osteoporotic vertebral body fracture patients on XP/CT, and T1 low-intensity STIR high-intensity change on MRI.
Key exclusion criteria
Patients with neurological symptoms due to bone fracture, not osteoporotic vertebral body fracture due to high energy trauma, pathological fractures (suppurative spondylitis, spinal tumor, etc.), steroid patients, dialysis patients, bedridden cases, unable to answer questionnaire thing
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Teraguchi |
Organization
Wakayama Medical University Kihoku Hospital, Japan.
Division name
Department of Orthopaedic Surgery Spine Care Center,
Zip code
649-7113
Address
Ito gun, Katsuragi town 219
TEL
0736-22-0066
masa_bomgoo7@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Teraguchi |
Organization
Wakayama Medical University Kihoku Hospital, Japan.
Division name
Department of Orthopaedic Surgery Spine Care Center
Zip code
649-7113
Address
Ito gun, Katsuragi town 219
TEL
0736-22-0066
Homepage URL
masa_bomgoo7@yahoo.co.jp
Sponsor or person
Institute
Wakayama Medical University Kihoku Hospital, Japan.
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University Kihoku Hospital, Japan.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama medical university
Address
Kimiidera 811-1
Tel
073-447-2300
wa-rinri@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jspineres/13/1/13_2021-0048/_pdf/-char/ja
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jspineres/13/1/13_2021-0048/_pdf/-char/ja
Number of participants that the trial has enrolled
118
Results
Our results revealed that radiological SF significantly increased in patients who had their diagnosis of OVF confirmed after 7 days of injury and in those who underwent BKP after 28 days of OVF diagnosis.
Results date posted
| 2024 | Year | 07 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 118 patients who were diagnosed with OVF and underwent BKP were analyzed.
Participant flow
After their OVF diagnosis was confirmed, patients were placed in a brace and hospitalized for BKP.
Adverse events
None
Outcome measures
Numerical rating scale (NRS) at 3 months post-BKP, radiological subsequent fracture (SF) at adjacent level, painful SF at adjacent level, and correction loss were used
as the objective variables for Fisher exact test. The time taken to confirm the diagnosis (within 7 days early diagnosisgroup vs. after 7 days of injury late diagnosis group) and the timing of BKP (within 28 days early BKP group vs. after 28 days of OVF diagnosis late BKP group) were used as explanatory variables, and a multivariate logistic regression analysis of the objective variables was performed after adjusting for sex, age, bone material density, and affected vertebrae level.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Report progress as appropriate.
Management information
Registered date
| 2020 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046604
