UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The related factors of independent cane gait after total hip arthroplasty(THA)-Initiating cane gait training on the post operative day 1 decreases the days until cane gait independence after total hip arthroplasty-
Title of the study (Brief title)	Initiating cane gait training on the post operative day 1 decreases the days until cane gait independence after total hip arthroplasty
Region	Japan

Condition
Condition	Hip Osteoarthritis
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to compare the days until cane gait independence between patients initiating cane gait training on the post operative day 1 after THA with those training on the post operative day 2. And we consider which training is effective after THA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	It is the possible or impossible of the cane gait independence on the post operative day 2 after THA.
Key secondary outcomes	Patients demographics: Age,sex,BMI,Affected side,surgical procedure,comorbidities,disease duration,preoperative physical function Postoperative physical function: Hip Range of motion,Hip abductor muscle strength,Single-limb stance time,Timed 10-meter walk test Inflammation findings: pain(rest,gait),C-reactive protein(CRP) Imaging fingings: Leg extention of intraoperative,Acetabular head index,Pelvic tilt angle

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Initiating cane gait training on the post operative day 1 after THA
Interventions/Control_2	Initiating cane gait training on the post operative day 2 after THA
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Primary THA 2)The operative day is Monday or Wednesday 3)Age is above 50 years 4)Patients that an agreement was provided
Key exclusion criteria	1)Patients who were operated on revision surgery 2)Patients with severe orthopedic disease 3)Patients with progressive disoeder of the nervous system ond muscle 4)Patients scheduled for arthroplasy with osteotomy 5)Patinets scheduled for arthroplasy with hip adductor muscle dehiscence 6)Patients with dementia 7)Patients with the depression or schizophrenic disorder 8)Patients with cerebro-vascular disease 9)Patients with untreated cardio-vascular disorder 10)Others who judged that a researcher was inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuo Hirakawa
Organization	Shonan Kamakura Joint Reconstruction Center
Division name	Department of Orthopedic
Address	5-4-17 Dai,Kamakura,Kanagawa,Japan
TEL	0466-47-2377
Email	mail@skjrc.jp

Public contact
Name of contact person	Kazunari Ninomiya
Organization	Shonan Kamakura Joint Reconstruction Center
Division name	Department of Rehabilitation
Address	5-4-17 Dai,Kamakura,Kanagawa,Japan
TEL	0466-47-2377
Homepage URL
Email	mail@skjrc.jp

Sponsor
Institute	Shonan Kamakura Joint Reconstruction Center
Institute
Department

Funding Source
Organization	Shonan Kamakura Joint Reconstruction Center
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	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人沖縄徳洲会　湘南鎌倉人工関節センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 10 Day
Anticipated trial start date	2017 Year 05 Month 08 Day
Last follow-up date
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

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

Management information
Registered date	2017 Year 05 Month 01 Day
Last modified on	2018 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031175