UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018101 |
|---|---|
| Receipt number | R000020949 |
| Scientific Title | Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study |
| Date of disclosure of the study information | 2015/06/26 |
| Last modified on | 2022/07/01 20:27:45 |
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Basic information
Public title
Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study
Acronym
Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study
Scientific Title
Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study
Scientific Title:Acronym
Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study
Region
| Japan |
Condition
Condition
Osteoarthritis, rheumatoid arthritis, osteonecrosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of venous thromboembolism (VTE) after total knee arthroplasty (TKA), opening wedge high tibial osteotomy (OWHTO) and closed wedge high tibial osteotomy (CWHTO) and to evaluate the efficacy and safety of edoxaban for the prevention of VTE in patients undergoing TKA and HTOs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Levels of coagulation and fibrinolysis markers are evaluated on the preoperative day and on postoperative days 1, 3, 7, and 14.
To determine whether postoperative VTE is present and to evaluate the efficacy and safety of edoxaban for the prevention of patients undergoing TKA, OWHTO, or CWHTO, angiography of the pulmonary artery and deep veins of the lower limbs is performed in all patients on postoperative day 7.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To determine whether postoperative VTE is present and to evaluate the efficacy and safety of edoxaban for the prevention of patients undergoing TKA, OWHTO, or CWHTO, angiography of the pulmonary artery and deep veins of the lower limbs is performed in all patients on postoperative day 7.
Interventions/Control_2
Levels of coagulation and fibrinolysis markers are evaluated on the preoperative day and on postoperative days 1, 3, 7, and 14.
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 with osteoarthritis, osteonecrosis, and rheumatoid arthritis undergoing TKA, OWHTO, and CWHTO.
Key exclusion criteria
Patients with the presence of pre-operative VTE, severe renal impairment, and the use of anticoagulants, antiplatelet agents, thrombolytic agents, and other agents that impact on thrombus formation, are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Kobayashi |
Organization
Yokohama City University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
045-787-2655
hi-deo@live.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideo Kobayashi |
Organization
Yokohama City University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
045-787-2800
Homepage URL
hi-deo@live.jp
Sponsor or person
Institute
Yokohama City University School of 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
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
| 2015 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 26 | Day |
Last modified on
| 2022 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020949
