UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062482 |
|---|---|
| Receipt number | R000071503 |
| Scientific Title | A study of deep vein thrombosis in total knee arthroplasty |
| Date of disclosure of the study information | 2026/08/05 |
| Last modified on | 2026/08/05 16:04:43 |
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Basic information
Public title
A study of deep vein thrombosis in total knee arthroplasty
Acronym
A study of deep vein thrombosis in total knee arthroplasty
Scientific Title
A study of deep vein thrombosis in total knee arthroplasty
Scientific Title:Acronym
A study of deep vein thrombosis in total knee arthroplasty
Region
| Japan |
Condition
Condition
total knee arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the incidence and risk factors of deep vein thrombosis (DVT) in patients undergoing total knee arthroplasty may provide valuable information for prevention, treatment, and preoperative informed consent.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
incidence of deep vein thrombosis
Key secondary outcomes
risk factors associated with the development of deep vein thrombosis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients who underwent total knee arthroplasty at our institution between July 2015 and June 2025
Key exclusion criteria
none
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | takeshi |
| Middle name | |
| Last name | mochizuki |
Organization
Kamagaya General Hospital, Tokushukai Medical Corporation
Division name
Department of Orthopedic Surgery
Zip code
273-0121
Address
929-6 Hatsutomi, Kamagaya City, Chiba 273-0121, Japan
TEL
047-498-8111
chiken@kamagaya-hp.jp
Public contact
Name of contact person
| 1st name | takeshi |
| Middle name | |
| Last name | mochizuki |
Organization
Kamagaya General Hospital, Tokushukai Medical Corporation
Division name
Department of Orthopedic Surgery
Zip code
273-1212
Address
929-6 Hatsutomi, Kamagaya City, Chiba 273-0121, Japan
TEL
047-489-8111
Homepage URL
chiken@kamagaya-hp.jp
Sponsor or person
Institute
Kamagaya General Hospital, Tokushukai Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Kamagaya General Hospital, Tokushukai Medical Corporation
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
Tokushukai Group Central Ethics Review Committee, Tokushukai General Incorporated Association
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
mirai-ec4@mirai-iryo.com
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
| 2026 | Year | 08 | Month | 05 | 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
600
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who underwent total knee arthroplasty at our institution between July 2015 and June 2025 were included in this study.
The study variables included patient background characteristics such as age, sex, height, body weight, body mass index, primary diagnosis at admission, comorbidities, and concomitant medications, as well as anesthesia, operative time, presence or absence of deep vein thrombosis, and blood test results including D-dimer, creatine phosphokinase, and hemoglobin.
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071503
