UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035944 |
|---|---|
| Receipt number | R000040915 |
| Scientific Title | Prospective comparative study between new and original approach for prevention of LFCN injury in THA with DAA |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2021/02/24 19:59:11 |
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Basic information
Public title
Prospective comparative study between new and original approach for prevention of LFCN injury in THA with DAA
Acronym
Prospective comparative study between new and original approach for prevention of LFCN injury in THA with DAA
Scientific Title
Prospective comparative study between new and original approach for prevention of LFCN injury in THA with DAA
Scientific Title:Acronym
Prospective comparative study between new and original approach 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
new approach
Interventions/Control_2
original 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
| 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
113-8431
Address
3-1-3,Hongo Bunkyo-ku,Tokyo
TEL
03-3813-3111
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
113-8431
Address
3-1-3,Hongo Bunkyo-ku,Tokyo
TEL
03-3813-3111
Homepage URL
tobaba@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
順天堂大学医学部附属順天堂医院(東京都)
順天堂大学医学部附属順天堂東京江東高齢者医療センター(東京都)
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040915
