UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The comparison study between the healthy persons in middle ages and elderly about lower extremity function and physical activity after total hip arthroplasty(THA) at 10-years.
Title of the study (Brief title)	The comparison between healthy persons in middle ages and elderly about lower extremity function.
Region	Japan

Condition
Condition	Hip osteoarthritis The healthy persons in middle ages and elderly
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare patients after THA at 10-years with the healthy persons in middle ages and eldery about lower extremity function and physical activity And consider the necessity of continued intervention to patients after THA at 10-years
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Hip abductor muscle strength
Key secondary outcomes	Physical activity (International Physical Activity Questionnaire(IPAQ)) 5-m timed gait test One leg standing test Lower limb circumferences Timed up and Go (TUG) test

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients after THA at 10-years 2)The healthy persons in middle ages and ellderly
Key exclusion criteria	1)Persons with past surgical history 2)Persons with progressive disorder of the nervous system and muscle 3)Persons scheduled for arthroplasy with osteotomy 4)Persons scheduled for arthroplasy with hip adductor muscle dehiscence 5)Persons with dementia 6)Persons with the depression or schizophrenic disorder 7)Persons with cerebro-vascular disease 8)Persons with untreated cardio-vascular disorder
Target sample size	111

Research contact person
Name of lead principal investigator	Kazuo Hirakawa
Organization	Shonan Kamakura Joint Reconstruction Center
Division name	Department of Orthopaedic Surgery
Address	5-4-17 Dai, Kamakura, Kanagawa, Japan
TEL	0467-47-2377
Email	mail@skjrc.jp

Public contact
Name of contact person	Koji Suzuki
Organization	Shonan Kamakura Joint Reconstruction Center
Division name	Department of Rehabilitation
Address	5-4-17 Dai, Kamakura, Kanagawa, Japan
TEL	0467-47-2377
Homepage URL
Email	reha@skjrc.jp

Sponsor
Institute	Shonan Kamakura Joint Reconstruction Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokushukai Kamakura Gymnastics Club
Name of secondary funｄer(s)

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	医療法人沖縄徳洲会　湘南鎌倉人工関節センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 08 Day
Anticipated trial start date	2015 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Influential factor: aging and THA. Outcome : lower extremity function and physical activity. Prospective stdy.

Management information
Registered date	2015 Year 08 Month 05 Day
Last modified on	2016 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021451