UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000054114
Receipt number R000061796
Scientific Title Epidemiological study of physical function and functional prognosis in postoperative patients with hip fracture. ~ A multicenter prospective cohort study~.
Date of disclosure of the study information 2024/04/11
Last modified on 2024/04/11 10:04:09

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Basic information

Public title

Epidemiological study of physical function and functional prognosis in postoperative patients with hip fracture.

Acronym

Epidemiological study of physical function and functional prognosis in postoperative patients with hip fracture.

Scientific Title

Epidemiological study of physical function and functional prognosis in postoperative patients with hip fracture.
~ A multicenter prospective cohort study~.

Scientific Title:Acronym

Epidemiological study of physical function and functional prognosis in postoperative patients with hip fracture.

Region

Japan


Condition

Condition

Hip fracture

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate factors (patient characteristics, medical and social factors) that influence mortality and functional prognosis in patients with hip fracture who have undergone surgery in a prospective study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Physical function: mobility at discharge, 10 m normal walking speed, Functional Independence Measure (day after surgery, 1 week, 4 weeks, 8 weeks, 12 weeks, at discharge)
Complications: DVT, falls, peroneal nerve palsy, infection
Mortality

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

18 years-old <=

Age-upper limit

120 years-old >

Gender

Male and Female

Key inclusion criteria

Inpatients aged 18 years and over who have been diagnosed and operated on for Hip fracture

Key exclusion criteria

When the patient/family member refuses to participate.
When the patient has a respiratory or circulatory disorder to the extent that the physical function assessment carried out in normal medical care is not possible.

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Nakamura
Middle name
Last name Keisuke

Organization

Shinshu University

Division name

Department of Physical Therapy, School of Health Sciences

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan

TEL

0263-35-4600

Email

keipons55@yahoo.co.jp


Public contact

Name of contact person

1st name Nakamura
Middle name
Last name Keisuke

Organization

Shinshu University

Division name

Department of Physical Therapy, School of Health Sciences

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan

TEL

0263-35-4600

Homepage URL


Email

keipons55@yahoo.co.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Japan society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shinshu University, School of Medicine, IRB

Address

Asahi 3-1-1, Matsumoto, Japan

Tel

0263-35-4600

Email

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

2024 Year 04 Month 11 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

Enrolling by invitation

Date of protocol fixation

2019 Year 09 Month 28 Day

Date of IRB

2019 Year 11 Month 12 Day

Anticipated trial start date

2019 Year 12 Month 01 Day

Last follow-up date

2024 Year 11 Month 12 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Data collection will be carried out at multiple centres in Nagano Prefecture. Multiple regression or logistic regression analysis will be performed with outcome as the dependent variable and patient background and rehabilitation progress information as independent variables.


Management information

Registered date

2024 Year 04 Month 11 Day

Last modified on

2024 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061796


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name