UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051396 |
|---|---|
| Receipt number | R000058635 |
| Scientific Title | Predicting early postoperative independence in toileting based on preinjury cognitive function in postoperative patients with proximal femur fractures. |
| Date of disclosure of the study information | 2023/06/21 |
| Last modified on | 2024/01/10 22:38:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Predicting early postoperative independence in toileting based on preinjury cognitive function in postoperative patients with proximal femur fractures
Acronym
Predicting early postoperative independence in toileting based on preinjury cognitive function in postoperative patients with proximal femur fractures.
Scientific Title
Predicting early postoperative independence in toileting based on preinjury cognitive function in postoperative patients with proximal femur fractures.
Scientific Title:Acronym
Predicting early postoperative independence in toileting based on preinjury cognitive function in postoperative patients with proximal femur fractures.
Region
| Japan |
Condition
Condition
Proximal femoral fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze and examine whether pre-injury cognitive function(The Dementia Assessment Sheet for Community-based Integrated Care System-21 items) can be a predictor of early postoperative (1.5 and 3 weeks) toileting independence in postoperative patients over 80 years of age after proximal femur fracture surgery.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to investigate whether pre-injury cognitive function influences the early acquisition of postoperative toileting independence by comparing the pre-injury DASC-21 scores of the groups with and without toileting independence at 1.5 weeks and 3 weeks postoperatively.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A multivariate analysis will be performed to determine whether the independent variables, including the following primary endpoints, affect the dependent variable.
Dependent Variables:Independence of toileting in the hospital's toilet at 1.5 weeks postoperatively.
Independent Variables:Pre-injury DASC-21 (primary endpoint),
Subject background, pre-injury physical function (secondary endpoints).
Dependent Variables:Independence of toileting in the hospital's toilet at 3 weeks postoperatively.
Independent Variables:Pre-injury DASC-21 (primary endpoint),
Subject background, pre-injury physical function (secondary endpoints).
Dependent Variables:Independence of toileting in the portable toilet at 1.5 weeks postoperatively.
Independent Variables:Pre-injury DASC-21 (primary endpoint),
Subject background, pre-injury physical function (secondary endpoints).
Dependent Variables:Independence of toileting in the portable toilet at 3 weeks postoperatively.
Independent Variables:Pre-injury DASC-21 (primary endpoint),
Subject background, pre-injury physical function (secondary endpoints).
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Proximal femur fracture patients aged 80 years or older who visited Aizawa Hospital and underwent surgery between August 1, 2021 and August 31, 2022.
Key exclusion criteria
1. Persons who required assistance with toileting prior to the injury.
2. Persons who cannot be interviewed by family members, supporters, or the individual about their cognitive function prior to the injury.
Target sample size
139
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Tomii |
Organization
Aizawa Hospital
Division name
Orthopedic Rehabilitation
Zip code
390-0814
Address
2-5-1 Honjo, Matsumoto City, Nagano, Japan
TEL
0263-33-8600
riha2@ai-hosp.or.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Tomii |
Organization
Aizawa Hospital
Division name
Orthopedic Rehabilitation
Zip code
390-0814
Address
2-5-1 Honjo, Matsumoto City, Nagano, Japan
TEL
0263-33-8600
Homepage URL
riha2@ai-hosp.or.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Shinshu University Research Ethics Committee, Department of Life Sciences and Medicine
Address
3-1-1 Asahi, Matsumoto City, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2023 | Year | 06 | Month | 21 | 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
135
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a backward-looking observational study. Sampling is done in a case-control fashion.
Management information
Registered date
| 2023 | Year | 06 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058635
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
