UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020378 |
|---|---|
| Receipt number | R000023537 |
| Scientific Title | Effect of difference of decubitus position in abducting the hip on function after hip replacement arthroplasty |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2018/01/02 08:30:52 |
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Basic information
Public title
Effect of difference of decubitus position in abducting the hip on function after hip replacement arthroplasty
Acronym
Comparative study of decubitus position in abducting the hip after hip replacement arthroplasty
Scientific Title
Effect of difference of decubitus position in abducting the hip on function after hip replacement arthroplasty
Scientific Title:Acronym
Comparative study of decubitus position in abducting the hip after hip replacement arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to show that the decubitus position in abducting the hip affects the function after hip replacement arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We assess the patients' physical findings; muscular strength, range of motion, muscular activities, pain and a walk ability. We assess them as follows, preoperative, postoperative day 3rd, and postoperative day 10th.
Key secondary outcomes
We assess the incidence of adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In supine group, the patients abduct the hip in supine ten times three sets after the operation. They abduct the hip from the day that physical therapy starts until the day that they leave the hospital. Physical therapy are done five days a week.
Interventions/Control_2
In prone group, the same physical therapy are done in prone.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects are the patients receiving total hip arthroplasty for unilateral osteoarthritis of the hip. And they walk in inverse Trendelenburg that sound side's pelves rise in loading response before the operation.
Key exclusion criteria
We exclude the patients that have high dislocation of Crowe type 3 and 4, that have had any surgeries of the lower limbs, that have rheumatoid arthritis, that have neuropathy, that have cognitive impairment, or that have arthrogryposis that they can't be in the neutral position of the hip before and after the operation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Jinno |
Organization
Tokyo Medical and Dental University
Division name
Department of Joint Surgery and Sports Medicune
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5273
jinno.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Ikematsu |
Organization
Tokyo Medical and Dental University
Division name
Department of Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5648
Homepage URL
ikematsu.phyt@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University, Department of Joint Surgery and Sports Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
YES
Study ID_1
2301
Org. issuing International ID_1
Faculty of Medicine, Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科歯科大学医学部附属病院（東京都）
Tokyo Medical and Dental University Hospital of Medicine
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2018 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023537
