UMIN-CTR Clinical Trial

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
Email	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
Email	hi-deo@live.jp

Sponsor
Institute	Yokohama City University School of Medicine
Institute
Department

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
Email

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020949