UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039567 |
|---|---|
| Receipt number | R000045120 |
| Scientific Title | Nutrition status and functional prognosis among elderly patients with distal radius fracture: a retrospective cohort study. |
| Date of disclosure of the study information | 2020/02/22 |
| Last modified on | 2020/04/20 04:44:34 |
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Basic information
Public title
Nutrition status and functional prognosis with distal radius fracture.
Acronym
Nutrition status and functional prognosis with distal radius fracture.
Scientific Title
Nutrition status and functional prognosis among elderly patients with distal radius fracture: a retrospective cohort study.
Scientific Title:Acronym
Nutrition status and functional prognosis with distal radius fracture.
Region
| Japan |
Condition
Condition
Distal radius fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to identify factors influencing functional prognosis and establish the optimal therapeutic intervention for prevention of falls by conducting a retrospective survey of patients with surgically treated distal radius fractures, including basic information, ADL, nutritional index, and the presence or absence of falls.
Basic objectives2
Others
Basic objectives -Others
The objective of this study was to identify factors influencing functional prognosis and establish the optimal therapeutic intervention for prevention of falls by conducting a retrospective survey of patients with surgically treated distal radius fractures, including basic information (Gender, age, height, weight, fracture classification, serum albumin level, complications), the Barthel index (BI) as an ADL index, the Geriatric Nutritional Risk Index (GNRI) as a nutritional index, and the presence or absence of falls.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Barthel index efficacy
Key secondary outcomes
presence of subsequent fall
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 65 years or older who underwent surgery for distal radius fracture between October 1, 2014 and December 31, 2018 who were followed up for 1 year after surgery
Key exclusion criteria
Cases of abasia and death before injury
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University Hospatal
Division name
Orthopedic surgery
Zip code
101-8309
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo
TEL
0332931711
ntnyf092@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University Hospital
Division name
Rehabilitation medicine
Zip code
101-8309
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo
TEL
0332931711
Homepage URL
ntnyf092@yahoo.co.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University 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
Nihon University Hospital
Address
1-6, Kandasurugadai, Chiyoda-ku, Tokyo
Tel
0332931711
ntnyf092@yahoo.co.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
| 2020 | Year | 02 | Month | 22 | 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
229
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
Main results already published
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There were 31 patients in the malnutrition group and 198 patients in the good nutrition group. Univariate analysis revealed significant differences in the body mass index (BMI), serum albumin level, CCI, admission and final BI, BI gain, and fall over rate among the subjects. The correlation between BI gain and each value in Spearman's rank correlation coefficient was positive for GNRI and serum albumin, and negative for CCI. Multiple regression analysis and logistic regression analysis showed that GNRI was related to BI gain and serum albumin was related to fall.
Management information
Registered date
| 2020 | Year | 02 | Month | 22 | Day |
Last modified on
| 2020 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045120
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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