UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052491 |
|---|---|
| Receipt number | R000059905 |
| Scientific Title | Dose perioperative blood lose decrease by using hip supporter brace ? A randomized control study |
| Date of disclosure of the study information | 2023/10/15 |
| Last modified on | 2023/10/13 16:53:06 |
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Basic information
Public title
Dose perioperative blood lose decrease by using hip supporter brace ? A randomized control study
Acronym
Dose perioperative blood lose decrease by using hip supporter brace ? A randomized control study
Scientific Title
Dose perioperative blood lose decrease by using hip supporter brace ? A randomized control study
Scientific Title:Acronym
Dose perioperative blood lose decrease by using hip supporter brace ? A randomized control study
Region
| Japan |
Condition
Condition
hip osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Blood loss following total hip arthroplasty (THA) often need blood transfusions, and swelling often causes pain. It was controversial with regard to the effectiveness whether the use of hip orthoses to prevent bleeding and swelling or not. The purpose of this study was to prospectively investigate whether the use of a hip orthosis after THA is effective in preventing bleeding and swelling.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The use of a hip supporter reduced perioperative blood loss or not
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
To compare the amount of blood loss (total perioperative blood loss on postoperative days 1, 3, and 7 calculated from the Gross formula) between the group using the hip supporter and the group not using the hip supporter after THA surgery.
Pain will be compared at 1, 3, and 7 days postoperatively using the Numeric Rating Scale (NRS).
Interventions/Control_2
To compare the amount of blood loss (total perioperative blood loss on postoperative days 1, 3, and 7 calculated from the Gross formula) between the group using the hip supporter and the group not using the hip supporter after THA surgery.
Pain will be compared at 1, 3, and 7 days postoperatively using the Numeric Rating Scale (NRS).
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients receiving THA at Niigata University Medical and Dental Hospital and Niigata Bandai Hospital.
Key exclusion criteria
Revision surgery cases
Patients with intraoperative fractures
Preoperative use of anticoagulants or antithrombotics
Inadequately sized hip brace (too small or too large)
Patient refuses to participate in the study or research
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | IMAI |
Organization
Niigata University
Division name
Div. of Comprehensive Musculoskeletal Medicine,
Zip code
951-8510
Address
1-757, Asahimachi-dori, Niigata City, Niigata Prefecture, Japan
TEL
08072071405
imainorio2001@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | Imai |
| Last name | IMAI |
Organization
Niigata University
Division name
Div. of Comprehensive Musculoskeletal Medicine
Zip code
951-8510
Address
1-757 Asahimachi-dori, Niigata City, Niigata Prefecture, Japan
TEL
08072071405
Homepage URL
imainorio2001@yahoo.co.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
none
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
Niigata University
Address
1-757 Asahimachi-dori, Niigata City, Niigata Prefecture, Japan
Tel
0252272272
imainorio2001@yahoo.co.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
| 2023 | Year | 10 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059905
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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