UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049439 |
|---|---|
| Receipt number | R000056290 |
| Scientific Title | Influence on physical function and QOL of surgical adult spinal deformity correction. |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/11/06 07:27:17 |
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Basic information
Public title
Influence on physical function and QOL of surgical adult spinal deformity correction.
Acronym
Influence on physical function and QOL of surgical adult spinal deformity correction.
Scientific Title
Influence on physical function and QOL of surgical adult spinal deformity correction.
Scientific Title:Acronym
Influence on physical function and QOL of surgical adult spinal deformity correction.
Region
| Japan |
Condition
Condition
adult spinal deformity
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify factors that physical function improvement and ADL after corrective spinal fixation (sacroiliac joint fusion).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
spinal pelvic alignment
Key secondary outcomes
Health-related QOL
Activity of daily living after long level fusion
voiding function
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
recieved surgery from December 2022 to December 2023
without serious complications
Key exclusion criteria
cannot follow test instructions
did not consent to study participation
serious postoperative complications
judged inappropriate by the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Nishida |
Organization
University of the Ryukyus
Division name
Orthopedic Surgery
Zip code
903-0215
Address
207 Uehara, Nishihara Town, Okinawa
TEL
098-895-1174
kotaronishida@hotmail.co.jp
Public contact
Name of contact person
| 1st name | satoko |
| Middle name | |
| Last name | Nagamine |
Organization
University of the Ryukyus Hospital
Division name
Rehabilitation services administration
Zip code
903-0215
Address
207 Uehara, Nishihara Town, Okinawa
TEL
098-895-3331
Homepage URL
mayfair55mini@yahoo.co.jp
Sponsor or person
Institute
University of the Ryukyus Hospital
Institute
Department
Personal name
Funding Source
Organization
University of the Ryukyus Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of the Ryukyus Hospital
Address
207 Uehara, Nishihara Town, Okinawa 903-0215
Tel
098-895-3331
kkamit@med.u-ryukyu.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
| 2022 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 11 | Month | 06 | Day |
Last modified on
| 2022 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056290
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| Registered date | File name |
| Research case data | |
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