UMIN-CTR Clinical Trial

Basic information
Public title	Prospective comparative study between lateral fascia incision and original for prevention of LFCN injury in THA with DAA.
Acronym	Prospective comparative study between lateral fascia incision and original for prevention of LFCN injury in THA with DAA.
Scientific Title	Prospective comparative study between lateral fascia incision and original for prevention of LFCN injury in THA with DAA.
Scientific Title:Acronym	Prospective comparative study between lateral fascia incision and original for prevention of LFCN injury in THA with DAA.
Region	Japan

Condition
Condition	hip joint disease
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Prevention of nurve injury
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	part of that feel discomfort details of discomfort movement of that feel discomfort presence or absence of symptom degree of symptom lost time of symptom
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	lateral fascia incision
Interventions/Control_2	original incision
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1.patient who are done by THA 2.patient who were consented 3.patient who were consented with their own will by documents after they were sufficiently explained about this study
Key exclusion criteria	1.previous hip surgery (THA revision, osteotomy) 2.septic arthritis 3.patients who don't observe doctoers' indication or can't observe because of mental disorder 4.severe obesity (BMI over 35) 5.patients who were judged as unsuitable
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tomonori Middle name Last name Baba
Organization	Juntendo University Hospital
Division name	Orthopedics
Zip code	1138431
Address	3-1-3,Hongo Bunkyo-ku,Tokyo
TEL	03-3813-3111
Email	tobaba@juntendo.ac.jp

Public contact
Name of contact person	1st name Tomonori Middle name Last name Baba
Organization	Juntendo University Hospital
Division name	Orthopedics
Zip code	1138431
Address	3-1-3,Hongo Bunkyo-ku,Tokyo
TEL	03-3813-3111
Homepage URL
Email	tobaba@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Juntendo Tokyo Koto Geriatric Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	research ethics committee
Address	3-1-3,Hongo Bunkyo-ku,Tokyo
Tel	03-3813-3111
Email	kenkyu5858@juntendo.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	2019 Year 03 Month 01 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	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 29 Day
Date of IRB	2019 Year 01 Month 31 Day
Anticipated trial start date	2019 Year 02 Month 20 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	2019 Year 02 Month 20 Day
Last modified on	2021 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040918