UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027212 |
|---|---|
| Receipt number | R000031175 |
| Scientific Title | 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- |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2018/02/19 10:21:09 |
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Basic information
Public title
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-
Acronym
Initiating cane gait training on the post operative day 1 decreases the days until cane gait independence after total hip arthroplasty
Scientific Title
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-
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazuo Hirakawa |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Orthopedic
Zip code
Address
5-4-17 Dai,Kamakura,Kanagawa,Japan
TEL
0466-47-2377
mail@skjrc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunari Ninomiya |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Rehabilitation
Zip code
Address
5-4-17 Dai,Kamakura,Kanagawa,Japan
TEL
0466-47-2377
Homepage URL
mail@skjrc.jp
Sponsor or person
Institute
Shonan Kamakura Joint Reconstruction Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031175
