UMIN-CTR Clinical Trial

Basic information
Public title	Prospective randomized comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.
Acronym	Comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.
Scientific Title	Prospective randomized comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.
Scientific Title:Acronym	Comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.
Region	Japan

Condition
Condition	Patients with unilateral total hip arthroplasty, osteoarthritis of the hip
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare clinical results between two types of intraoperative body position in total hip arthroplasty.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative clinical results
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	An unilateral total hip arthroplasty
Interventions/Control_2	The choice of two types of body position in total hip arthroplasty is randomized.
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	Patients receiving unilateral total hip arthroplasty.
Key exclusion criteria	Exclusion criteria of the patients are as follows. (1) Patients lacking ability to agree or ability to express agreement for participation appropriately in this study. (2) Severe contracture of the hip
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Ryohei Middle name Last name Takada
Organization	Medical Hospital, Tokyo Medical and Dental University
Division name	Department of orthopedic surgery
Zip code	113-8519
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	0358035279
Email	takada.orth@tmd.ac.jp

Public contact
Name of contact person	1st name Ryohei Middle name Last name Takada
Organization	Medical Hospital, Tokyo Medical and Dental University
Division name	Department of orthopedic surgery
Zip code	113-8519
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	0358035279
Homepage URL
Email	takada.orth@tmd.ac.jp

Sponsor
Institute	Department of Orthopedic Surgery , Medical Hospital, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University Hospital
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel	03-3813-6111
Email	takada.orth@tmd.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	2016 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	30
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	Completed
Date of protocol fixation	2016 Year 03 Month 01 Day
Date of IRB	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 26 Day
Last modified on	2022 Year 03 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024942