UMIN-CTR Clinical Trial

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