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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000039567
Receipt No. 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

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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
Email 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
Email ntnyf092@yahoo.co.jp

Sponsor
Institute Nihon University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045120

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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