UMIN-CTR Clinical Trial

Basic information
Public title	Gait analysis pre and post total hip arthroplasty -comparison of posterolateral approach and anterolateral approach-
Acronym	Gait analysis pre and post total hip arthroplasty -comparison of posterolateral approach and anterolateral approach-
Scientific Title	Gait analysis pre and post total hip arthroplasty -comparison of posterolateral approach and anterolateral approach-
Scientific Title:Acronym	Gait analysis pre and post total hip arthroplasty -comparison of posterolateral approach and anterolateral approach-
Region	Japan

Condition
Condition	Osteoarthritis of the hip, Idiopathic osteonecrosis of the femoral head
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This aim of this study is to evaluate gait between different approaches of total hip arthroplasty
Basic objectives2	Others
Basic objectives -Others	Evaluation of the difference between posterior approach and anterolateral approach
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	gait analysis
Key secondary outcomes	muscle and exercise peformance

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	posterior approach
Interventions/Control_2	anterolateral approach
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients who agree the research content 2.Patients who undergo total hip arthroplasty for osteoarthritis of the hip or idiopathic osteonecrosis of the femoral head 3.Patients who have undergone ipsilateral hip surgery
Key exclusion criteria	1.Patients who have active mental disorder 2.Patients who have dementia 3.Patients who are unable to walk by themselves before operation
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Taku Middle name Last name Ukai
Organization	Tokai University
Division name	Department of orthopaedic surgery
Zip code	259-1193
Address	Shimokasuya 143-1, Isehara
TEL	0463-93-1121
Email	taku115@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	1st name Taku Middle name Last name Ukai
Organization	Tokai University
Division name	Department of orthopaedic surgery
Zip code	259-1193
Address	Shimokasuya 143-1, Isehara
TEL	0463-93-1121
Homepage URL
Email	taku115@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University
Institute
Department

Funding Source
Organization	No funding
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	Tokai University
Address	Shimokasuya 143-1, Isehara
Tel	0463-93-1121
Email	taku115@is.icc.u-tokai.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	2022 Year 02 Month 08 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	2021 Year 11 Month 01 Day
Date of IRB	2021 Year 11 Month 04 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2026 Year 01 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 12 Month 20 Day
Last modified on	2021 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051885