UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of difference of decubitus position in abducting the hip on function after hip replacement arthroplasty
Title of the study (Brief title)	Comparative study of decubitus position in abducting the hip after hip replacement arthroplasty
Region	Japan

Condition
Condition	Osteoarthritis of the hip
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to show that the decubitus position in abducting the hip affects the function after hip replacement arthroplasty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	We assess the patients' physical findings; muscular strength, range of motion, muscular activities, pain and a walk ability. We assess them as follows, preoperative, postoperative day 3rd, and postoperative day 10th.
Key secondary outcomes	We assess the incidence of adverse events.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	In supine group, the patients abduct the hip in supine ten times three sets after the operation. They abduct the hip from the day that physical therapy starts until the day that they leave the hospital. Physical therapy are done five days a week.
Interventions/Control_2	In prone group, the same physical therapy are done in prone.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects are the patients receiving total hip arthroplasty for unilateral osteoarthritis of the hip. And they walk in inverse Trendelenburg that sound side's pelves rise in loading response before the operation.
Key exclusion criteria	We exclude the patients that have high dislocation of Crowe type 3 and 4, that have had any surgeries of the lower limbs, that have rheumatoid arthritis, that have neuropathy, that have cognitive impairment, or that have arthrogryposis that they can't be in the neutral position of the hip before and after the operation.
Target sample size	20

Research contact person
Name of lead principal investigator	Tetsuya Jinno
Organization	Tokyo Medical and Dental University
Division name	Department of Joint Surgery and Sports Medicune
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5273
Email	jinno.orth@tmd.ac.jp

Public contact
Name of contact person	Koji Ikematsu
Organization	Tokyo Medical and Dental University
Division name	Department of Rehabilitation
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5648
Homepage URL
Email	ikematsu.phyt@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University, Department of Joint Surgery and Sports Medicine
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	2301
Org. issuing International ID_1	Faculty of Medicine, Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京医科歯科大学医学部附属病院（東京都） Tokyo Medical and Dental University Hospital of Medicine

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 28 Day
Last modified on	2018 Year 01 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023537