UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective observational study to predict functional outcome of total hip arthroplasty(THA)
Title of the study (Brief title)	Retrospective observational study to predict functional outcome of total hip arthroplasty(THA)
Region	Japan

Condition
Condition	Hip osteoarthritis patients who underwent a primary THA
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the factor that influence the functional outcome of total hip arthroplasty
Basic objectives2	Others
Basic objectives -Others	To investigate the factor that influence the functional outcome of total hip arthroplasty
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Physical function:Japanese Orthopedic Association Hip Disease Evaluation Questionnaire(JHEQ)/Movement sub score
Key secondary outcomes	Motor function:Range of motion(ROM),Hip abductor and knee extensor strength Ambulatory ability:Timed "Up & Go" test(TUG) Quality of Life(QOL):JHEQ Psychological state:JHEQ/Mental sub score,modified Gait Efficacy Scale(mGES) Physical activity:Life Space Assessment(LSA)

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Primary THA patients who completed follow-up for 6 months postoperatively.
Key exclusion criteria	Rheumatoid arthritis Osteonecrosis of femoral head Revision THA Neurological disorder Cognitive impairment Missing data
Target sample size	100

Research contact person
Name of lead principal investigator	Masato Kugo
Organization	Shiga University of Medical Science Hospital
Division name	Rehabilitation Units
Address	Seta Tsukinowa-cho,Otsu,Shiga
TEL	077-548-2670
Email	9563@belle.shiga-med.ac.jp

Public contact
Name of contact person	Masato Kugo
Organization	Shiga University of Medical Science Hospital
Division name	Rehabilitation Units
Address	Seta Tsukinowa-cho,Otsu,Shiga
TEL	077-548-2670
Homepage URL
Email	9563@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science Hospital
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	no
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	滋賀医科大学医学部附属病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 07 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	A total of 233 patients underwent THA at the Department of Orthopedic Surgery in Shiga University of Medical Science Hospital between April 2013 and March 2016.The study participants who met the inclusion and exclusion criteria were approximately 100 patients.

Management information
Registered date	2016 Year 07 Month 07 Day
Last modified on	2016 Year 07 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026566